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510(k) K931266

BATTERY PACK #1012NC by Portable Power Systems, Inc. — Product Code LDD

K931266 is an FDA 510(k) premarket notification submitted by Portable Power Systems, Inc. for the device "BATTERY PACK #1012NC". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Portable Power Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
March 8, 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.

  • 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)
  • K934439 — RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR (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)
  • K932823 — BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK (February 17, 1994)
  • K934508 — BATTERY PACK# S1024NC (February 17, 1994)

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • 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)

FDA data resources