Medical Device Manufacturer · US , Mchenry , IL

Brentwood Instruments, Inc. - FDA 510(k) Cleared Devices

21 submissions · 20 cleared · Since 1981

Recent clearances: SPIROSCAN 4000, RHYTHMSCAN HR HOLTER RECORDER, RHYTHMSCAN

21

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Brentwood Instruments, Inc. Cardiovascular ✕

19 devices

1-12 of 19

Cleared Aug 02, 1988

RHYTHMSCAN HR HOLTER RECORDER

Cardiovascular · 55d

Cleared Feb 22, 1988

Cardiovascular · 306d

Cleared Mar 31, 1986

FUKUDA DENSHI CARDIMAX FCP-211

Cardiovascular · 87d

Cleared Feb 06, 1986

CARDIMAX FX-1164

Cardiovascular · 133d

Cleared Feb 04, 1986

CARDIMAX FX-406U

Cardiovascular · 84d

Cleared May 15, 1985

R-1000 ECG RECEIVER

Cardiovascular · 57d

Cleared May 15, 1985

T-1000 ECG TRANSMITTER

Cardiovascular · 57d

Cleared Mar 01, 1985

BRENTWOOD EZ SCAN 200 AMBULATORY ECG

Cardiovascular · 214d

Cleared Jan 10, 1985

FUKUDA DENSHI MODEL FCP-220

Cardiovascular · 52d

Cleared Sep 11, 1984

FUKUDA DENSHI FX-302 AUTO/THREE CHAN

Cardiovascular · 335d

Cleared May 09, 1984

FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN

Cardiovascular · 210d

Cleared Mar 13, 1984