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510(k) K941995

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

K941995 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 ST on July 26, 1994. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. National Custom Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
July 26, 1994
Date Received
April 25, 1994
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 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)
  • K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (September 12, 2001)
  • K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (September 12, 2001)
  • K012259 — MEDFUSION 2001 & 2010, MODEL N7215IWC (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)
  • K943680 — NCE REPLACEMENT BATTERIES (November 4, 1994)
  • K942629 — NCE REPLACEMENT BATTERIES (August 18, 1994)
  • K942244 — REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE (June 24, 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