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510(k) K946080

PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR by Portable Power Systems, Inc. — Product Code FCO

K946080 is an FDA 510(k) premarket notification submitted by Portable Power Systems, Inc. for the device "PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR". The FDA issued a decision of Substantially Equivalent on August 2, 1995. The device falls under product code FCO (Box, Battery, Rechargeable), a Class I device regulated under 21 CFR 876.1500. Portable Power Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1995
Date Received
December 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Box, Battery, Rechargeable
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Portable Power Systems, Inc.

  • K970234 — SEALED LEAD ACID BATTERY PACK (May 2, 1997)
  • K945043 — BATTERY PACK #PMX120-18A (January 20, 1995)
  • K931484 — REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S (February 17, 1994)
  • K934439 — RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR (February 17, 1994)
  • K931348 — BATTERY PACK #1005NC (February 17, 1994)
  • K933065 — BATTERY PACK# S1009LA (February 17, 1994)
  • K931483 — REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. (February 17, 1994)
  • K932823 — BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK (February 17, 1994)
  • K934508 — BATTERY PACK# S1024NC (February 17, 1994)
  • K934015 — RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB (February 17, 1994)

Other clearances for product code FCO

  • K944389 — R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 (March 23, 1995)
  • K944348 — R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 (March 23, 1995)
  • K945870 — R&D PART NOS. 5490, 5541, 5358, 5497 (March 23, 1995)
  • K944388 — R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 (March 23, 1995)
  • K944521 — RECHARGEABLE BATTERIES (March 6, 1995)
  • K945868 — R&D PART NOS. 5262, 5543, 5432, 5469 (March 6, 1995)
  • K944387 — R&D BATTERIES PART NOS. 5186 AND 5230 (March 2, 1995)
  • K944390 — R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 (February 27, 1995)
  • K945869 — R&D PART NOS. 5443, 5322, 5448, 5492 (February 27, 1995)
  • K945871 — R&D PART NOS. 5339, 5510, 5514 (February 27, 1995)

FDA data resources