510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934067Substantially Equivalent

Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10

National Custom Ent., Inc., Burnsville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934067 is the FDA 510(k) clearance record for POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10, a class III device, cleared for National Custom Ent., Inc. on under FDA product code DRK (Dc-Defibrillator, High Energy, (Including Paddles)). FDA's definition for product code DRK reads: "PMA to be filed by 12/26/96 (FR 50706 (9/27/96))". FDA records list 12 510(k) clearances for National Custom Ent., Inc., from to . As of , FDA records show no recalls naming K934067.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DRK Dc-Defibrillator, High Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class III
Review panel
Cardiovascular
Applicant
National Custom Ent., Inc. 400 Gateway Blvd., Burnsville MN
510(k) summary
Summary
Third party review
No

Clearances, product code DRK

Trailing 12 months

FDA records hold no clearances under product code DRK in the trailing twelve months.

FDA records show no clearances under product code DRK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260