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510(k) K141795

BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 by R & D Batteries, Inc. — Product Code MKJ

K141795 is an FDA 510(k) premarket notification submitted by R & D Batteries, Inc. for the device "BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500". The FDA issued a decision of Substantially Equivalent on December 8, 2014. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. R & D Batteries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2014
Date Received
July 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated External Defibrillators (Non-Wearable)
Device Class
Class III
Regulation Number
870.5310
Review Panel
CV
Submission Type

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Other clearances by R & D Batteries, Inc.

  • K951279 — R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199 (August 18, 1995)
  • K951400 — R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536 (August 18, 1995)
  • K951276 — R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438 (August 18, 1995)
  • K951282 — R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061 (August 18, 1995)
  • K951284 — R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155 (August 18, 1995)
  • K951280 — R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 5012 (August 18, 1995)
  • K951404 — R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131 (August 18, 1995)
  • K951401 — R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051 (August 18, 1995)
  • K951399 — R&D BATTERIES PART NOS. 5041 & 5655 (August 18, 1995)
  • K951283 — R&D BATTERIES, INC. PART NUMBERS 5075-B, 5076, 5122 AND 5123 (August 18, 1995)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K142709 — samaritan PAD 450P (March 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (January 23, 2015)
  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K142803 — Skintact, various other tradenames (December 2, 2014)
  • K141231 — ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (November 25, 2014)

FDA data resources