P117AUG312010详解.PDFVIP

KlMOboG P117 AUG 3 1 2010 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92. 1. The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH H-ewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ±+49 7031 463-2840, Fax: ++49 7031 463-2442 e-mail: markus -stacha~philips .corn This summary was prepared on June 02, 2010. 2. The names of the devices are: New devices: Trade name: Philips IntelliVue CL S902 Pod Common name: Telemetry Transceiver Trade name: Philips IntelliVue CL NEP Pod Common name: Telemetry Transceiver Modified devices: Trade names: Philips IntelliVue Patient Monitors MPS, MPST, MP2, X2 Common names: Multiparameter Patient Monitors Trade name: Philips Intellivue Telemetry System Transceiver TRx4S4lA Common name: Telemetry Transceiver Classification names are as follows: Device Panel Classification -ProCode . Description cardiovascular §870 .1025, II DSI Detector and Alarm, Arrhythmia _____ ___ Devices §870.1100, IT DSJ Alarm, Blood-Pressure §870.1110, IT DSK Computer, Blood-Pressure §870.1120, II DXQ Cuff, Blood-Pressure §870.1130, 1I DXN System, Measurement, Blood- Pressure, Non-Invasive §870.1435,IIComputer,