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510(k) K944386

R&D BATTERIES PART NOS. 5354 AND 5150 by R & D Batteries, Inc. — Product Code FCO

K944386 is an FDA 510(k) premarket notification submitted by R & D Batteries, Inc. for the device "R&D BATTERIES PART NOS. 5354 AND 5150". The FDA issued a decision of Substantially Equivalent on December 30, 1994. The device falls under product code FCO (Box, Battery, Rechargeable), a Class I device regulated under 21 CFR 876.1500. R & D Batteries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1994
Date Received
September 7, 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 R & D Batteries, Inc.

  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (December 8, 2014)
  • 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)
  • K951399 — R&D BATTERIES PART NOS. 5041 & 5655 (August 18, 1995)
  • K951276 — R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438 (August 18, 1995)
  • K951400 — R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536 (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)
  • K951279 — R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199 (August 18, 1995)

Other clearances for product code FCO

  • K946080 — PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR (August 2, 1995)
  • K944388 — R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 (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)
  • K944389 — R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 (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)
  • K945871 — R&D PART NOS. 5339, 5510, 5514 (February 27, 1995)
  • K944390 — R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 (February 27, 1995)

FDA data resources