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510(k) K934015

RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB by Portable Power Systems, Inc. — Product Code LDD

Clearance Details

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

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

Other clearances by Portable Power Systems, Inc.

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  • 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)
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  • K934439 — RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR (February 17, 1994)
  • K934508 — BATTERY PACK# S1024NC (February 17, 1994)
  • K931483 — REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. (February 17, 1994)

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  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)