PDF-510k SUMMARYThis summary of 510k safety and effectiveness informat

Device DescriptionThe Access Intact PTH reagents calibrators and the Access Immunoassay Analyzers AccessAccess 2 Synchron LXi 725 UniCel DxC600i and UniCel Dxl 800 comprise the AccessImmunoass. DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k072816 B. Purpose for Submission: New Device C. Measurand: Breath Nitric Oxide D. Type of Test: Quantitative Page Ilof 3 MAR I0 7-Feb-IlI Joan E. Spiegel, M.D. 10 Coleman Ct. Tel -617-935-3500 Natick, MA 01760 Official Contact: Joan Spiegel, M.D. Proprietary or Trade Name: Easy Cuffrm Common/Usual Name: Cuff 5 - 2 C Predicate Device Comparis on : Lepu Medical Technology (Beijing) Co., Ltd. added two models to the Radial Sheath Introducer, the sheath introducer radiocontrast agent was changed from Bismu SpccitI] SI Ilk ]'C(IiIII1C \VCui,,,Is ]lIKJClHILIJICI '[I[/1l0 I 011t I~ l I O 1IS C N [[ ] IIct S I CII, ( IIl{IfII T III II]%oiSa Ion II I5 1O(k) iSummar arid (jCTifilicaltio11TenderFlowTM Pediatri Nalu PNS 510(k) S ection 5 510(k) Summary p. 5 - 2 of 19 Medtronic and ANS devices are part of the predicate history of the StimQ device and are also used as references devices in this 510 (k). 5. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ServiceFood and Drug Administration9200 Corporate BoulevardRockville MD 20850MAR 20f8Ms. Helen LewisDirector of Corporate Compliance and Regulatory 7. Performance In terms of Physical specification, Chemical specification, BiologicalSummary: specification & Sterilization Specification, the device conforms toapplicable standards included ISO 7864, diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff thatis wrapped around the upper arm, a LCD display, a semiconductor sensor, andinternal air pump, a battery power sou 2 DeviceProprietary Name Cadence Ante parturn Fetal Monitormodel 2001 Singleton and model2002 TwinsCommon Name Fetal MonitorClassification Name 21 CFR 8842740 SystemMonitoring PerinatalProduct Code HG Page Ilof 3 MAR I07-Feb-IlIJoan E Spiegel MD10 Coleman Ct Tel -617-935-3500Natick MA 01760Official Contact Joan Spiegel MDProprietary or Trade Name Easy CuffrmCommon/Usual Name Cuff tracheal tube infl Intended Use / Indications for Use e dl tThe Medic4AII Telemedicine System Model VMS-01 is intended to collectand transmit physiological information such as non-invasive blood pressure viastandard tel INVIVO CORPORATION 510K NOTIFICATION3160 MRI PATIENT MONITORING SYSTEMA combination of wireless communication radio frequency RF shielding digital signalprocessing DSP and adaptable mounting technolog It\'s Time to Get Your Medical Device 510k Submitted and Approved. You\'ve designed your medical device and are ready to get it to market. But before you take that step, it is important to understand the process for approval for marketing in the US. 510(k) Summary JUL 2 62012 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMVDA and 21 CFR 507.92. 1.0 submitter's information- Na