Medical Device Manufacturer · US , Mchenry , IL

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

21 submissions · 20 cleared · Since 1981
21
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Brentwood Instruments, Inc. Cardiovascular
19 devices
1-19 of 19
Cleared Aug 02, 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366 · DSH
Cardiovascular · 55d
Cleared Feb 22, 1988
RHYTHMSCAN
K871572 · DSI
Cardiovascular · 306d
Cleared Mar 31, 1986
FUKUDA DENSHI CARDIMAX FCP-211
K860024 · DSI
Cardiovascular · 87d
Cleared Feb 06, 1986
CARDIMAX FX-1164
K853979 · DPS
Cardiovascular · 133d
Cleared Feb 04, 1986
CARDIMAX FX-406U
K854505 · DRS
Cardiovascular · 84d
Cleared May 15, 1985
R-1000 ECG RECEIVER
K851123 · DXH
Cardiovascular · 57d
Cleared May 15, 1985
T-1000 ECG TRANSMITTER
K851124 · DXH
Cardiovascular · 57d
Cleared Mar 01, 1985
BRENTWOOD EZ SCAN 200 AMBULATORY ECG
K842976 · DSI
Cardiovascular · 214d
Cleared Jan 10, 1985
FUKUDA DENSHI MODEL FCP-220
K844470 · DPS
Cardiovascular · 52d
Cleared Sep 11, 1984
FUKUDA DENSHI FX-302 AUTO/THREE CHAN
K833594 · DRT
Cardiovascular · 335d
Cleared May 09, 1984
FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN
K833593 · DPS
Cardiovascular · 210d
Cleared Mar 13, 1984
FCP-11ECG
K842169
Cardiovascular
Cleared Jul 28, 1983
AMBULATORY ECG EVENT RECORDER
K830907 · DSH
Cardiovascular · 129d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13
K823585 · DSI
Cardiovascular · 121d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200
K823586 · DSI
Cardiovascular · 121d
Cleared Dec 30, 1982
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-
K823584 · DPS
Cardiovascular · 24d
Cleared Dec 14, 1981
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36
K813021 · DPS
Cardiovascular · 48d
Cleared Dec 02, 1981
FUKUDA DENSHI CARDIMAX FK-12
K813022 · DPS
Cardiovascular · 36d
Cleared Dec 02, 1981
FUKUDA DENSHI CARDIMAX FK-11
K813023 · DSP
Cardiovascular · 36d
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