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510(k) K050151

MULTIDIAGNOST ELEVA by Philips Medical Systems North America, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2005
Date Received
January 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K082280 — SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 (October 8, 2008)
  • K063781 — PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE (January 5, 2007)
  • K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR (November 22, 2006)
  • K062268 — MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A0 (October 18, 2006)
  • K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MO (September 20, 2006)
  • K061685 — PULSERA (September 15, 2006)

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