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510(k) K934067

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 by National Custom Ent., Inc. — Product Code DRK

K934067 is an FDA 510(k) premarket notification submitted by National Custom Ent., Inc. for the device "POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10". The FDA issued a decision of Substantially Equivalent on October 7, 1993. The device falls under product code DRK (Dc-Defibrillator, High Energy, (Including Paddles)), a Class III device regulated under 21 CFR 870.5300. National Custom Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1993
Date Received
August 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, High Energy, (Including Paddles)
Device Class
Class III
Regulation Number
870.5300
Review Panel
CV
Submission Type

PMA to be filed by 12/26/96 (FR 50706 (9/27/96))

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)
  • K943680 — NCE REPLACEMENT BATTERIES (November 4, 1994)
  • K942629 — NCE REPLACEMENT BATTERIES (August 18, 1994)
  • K941995 — NCE REPLACEMENT BATTERIES (July 26, 1994)

FDA data resources