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510(k) K042867

PHILIPS ORTHOPAEDIC APPLICATIONS by Philips Medical Systems North America, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2004
Date Received
October 18, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
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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