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510(k) K934439

RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR by Portable Power Systems, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1994
Date Received
August 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Portable Power Systems, Inc.

  • K970234 — SEALED LEAD ACID BATTERY PACK (May 2, 1997)
  • K946080 — PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR (August 2, 1995)
  • K945043 — BATTERY PACK #PMX120-18A (January 20, 1995)
  • K932823 — BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK (February 17, 1994)
  • K931348 — BATTERY PACK #1005NC (February 17, 1994)
  • K931484 — REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S (February 17, 1994)
  • K933065 — BATTERY PACK# S1009LA (February 17, 1994)
  • K931483 — REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. (February 17, 1994)
  • K934015 — RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB (February 17, 1994)
  • K934508 — BATTERY PACK# S1024NC (February 17, 1994)

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