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510(k) K943680

NCE REPLACEMENT BATTERIES by National Custom Ent., Inc. — Product Code FCO

K943680 is an FDA 510(k) premarket notification submitted by National Custom Ent., Inc. for the device "NCE REPLACEMENT BATTERIES". The FDA issued a decision of Substantially Equivalent on November 4, 1994. The device falls under product code FCO (Box, Battery, Rechargeable), a Class I device regulated under 21 CFR 876.1500. National Custom Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1994
Date Received
July 26, 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 National Custom Ent., Inc.

  • K012264 — MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC (October 10, 2001)
  • K012263 — MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 (October 10, 2001)
  • K012259 — MEDFUSION 2001 & 2010, MODEL N7215IWC (September 12, 2001)
  • K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (September 12, 2001)
  • K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (September 12, 2001)
  • K012229 — SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C (September 10, 2001)
  • K943632 — REPLACEMENT BATTERIES (November 4, 1994)
  • K942629 — NCE REPLACEMENT BATTERIES (August 18, 1994)
  • K941995 — NCE REPLACEMENT BATTERIES (July 26, 1994)
  • K942244 — REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE (June 24, 1994)

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