Medical Device Manufacturer · US , Burnsville , MN

National Custom Ent., Inc. - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 1993

12

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - National Custom Ent., Inc. Cardiovascular ✕

5 devices

1-5 of 5

Cleared Oct 10, 2001

MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024

Cardiovascular · 84d

Cleared Oct 10, 2001

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

Cardiovascular · 84d

Cleared Aug 18, 1994

NCE REPLACEMENT BATTERIES

Cardiovascular · 76d

Cleared Jul 26, 1994

NCE REPLACEMENT BATTERIES

Cardiovascular · 92d

Cleared Oct 07, 1993

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10

Cardiovascular · 48d