510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K941995Substantially Equivalent - Subject to Tracking Reg.

Nce Replacement Batteries

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

K941995 is the FDA 510(k) clearance record for NCE REPLACEMENT BATTERIES, a class II device, cleared for National Custom Ent., Inc. on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list 12 510(k) clearances for National Custom Ent., Inc., from to . As of , FDA records show no recalls naming K941995.

Clearance record

Decision date
Received
(92 days to decision)
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
National Custom Ent., Inc. 400 Gateway Blvd., Burnsville MN
Third party review
No

Clearances, product code LDD

Trailing 12 months

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

FDA records show no clearances under product code LDD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDD, 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