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Company · US

National Custom Ent., Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2001. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
DPS	Electrocardiograph	3
MRZ	Accessories, Pump, Infusion	3
FCO	Box, Battery, Rechargeable	2
DRK	Dc-Defibrillator, High Energy, (Including Paddles)	1
ERA	Otoscope	1
FMT	Warmer, Infant Radiant	1
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 10, 2001	K012264	MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC National Custom Ent., Inc.	DPS
Oct 10, 2001	K012263	MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 National Custom Ent., Inc.	DPS
Sep 12, 2001	K012266	SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 National Custom Ent., Inc.	MRZ
Sep 12, 2001	K012262	BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC National Custom Ent., Inc.	MRZ
Sep 12, 2001	K012259	MEDFUSION 2001 & 2010, MODEL N7215IWC National Custom Ent., Inc.	MRZ
Sep 10, 2001	K012229	SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC National Custom Ent., Inc.	FMT
Nov 4, 1994	K943680	NCE REPLACEMENT BATTERIES National Custom Ent., Inc.	FCO
Nov 4, 1994	K943632	REPLACEMENT BATTERIES National Custom Ent., Inc.	FCO
Aug 18, 1994	K942629	NCE REPLACEMENT BATTERIES National Custom Ent., Inc.	DPS
Jul 26, 1994	K941995	NCE REPLACEMENT BATTERIES National Custom Ent., Inc.	LDD
Jun 24, 1994	K942244	REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE National Custom Ent., Inc.	ERA
Oct 7, 1993	K934067	POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 National Custom Ent., Inc.	DRK

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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