Medical Device Manufacturer · US , Eden Prairie , MN

Edentec Corp. - FDA 510(k) Cleared Devices

18 submissions · 17 cleared · Since 1985

18

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Edentec Corp. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Aug 29, 1991

EDENTEC MODEL 3711 DIGITAL RECORDER

Cardiovascular · 181d

Cleared Aug 29, 1991

EDENTEC DIGITAL CHARTER MODEL 3710

Cardiovascular · 181d

Cleared Aug 25, 1989

EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.

Cardiovascular · 108d

Cleared Jun 20, 1989

EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)

Cardiovascular · 77d

Cleared Jan 10, 1989

EDENTEC MODEL 4700 SCANNER

Cardiovascular · 84d

Cleared Dec 28, 1988

EDENTRACE MULTI-CHARTER MODEL 3700

Cardiovascular · 145d