Medical Device Manufacturer · US , Mchenry , IL

Telediagnostic Systems, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1978

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Telediagnostic Systems, Inc. Neurology ✕

11 devices

1-11 of 11

Cleared Sep 05, 2007

ALPHAONE BIOFEEDBACK SYSTEM

Neurology · 78d

Cleared Dec 31, 2002

NIGHTRON POLYSOMNOGRAPHY SYSTEM

Neurology · 172d

Cleared May 16, 1997

DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER

Neurology · 84d

Cleared Jun 18, 1991

VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM

Neurology · 271d

Cleared Jan 18, 1991

VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER

Neurology · 127d

Cleared Mar 22, 1989

RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER

Neurology · 84d

Cleared Dec 05, 1988

ISO-100 ISOLATION AMPLIFIER

Neurology · 77d

Cleared Dec 11, 1987

S-10 TELEPHONIC POLYSOMNOGRAPH

Neurology · 52d

Cleared May 01, 1987

M10 EEG MONITOR SCOPE

Neurology · 43d

Cleared Nov 26, 1980

MODEL T-6 EEG TELEPHONE TRANSMITTER

Neurology · 33d

Cleared Nov 12, 1980

MODEL AFR EEG TELEPHONE RECEIVER

Neurology · 19d