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Telediagnostic Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K071661ALPHAONE BIOFEEDBACK SYSTEMSeptember 5, 2007
K022249NIGHTRON POLYSOMNOGRAPHY SYSTEMDecember 31, 2002
K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERMay 16, 1997
K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMJune 18, 1991
K904222VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIERJanuary 18, 1991
K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERMarch 22, 1989
K884891OC-100 OXIMETER INTERFACE CALIBRATORDecember 28, 1988
K883947ISO-100 ISOLATION AMPLIFIERDecember 5, 1988
K874257S-10 TELEPHONIC POLYSOMNOGRAPHDecember 11, 1987
K871120M10 EEG MONITOR SCOPEMay 1, 1987
K810872EEG TELEPHONE RECEIVER MODEL #AFR-JMay 1, 1981
K802656MODEL T-6 EEG TELEPHONE TRANSMITTERNovember 26, 1980
K802657MODEL AFR EEG TELEPHONE RECEIVERNovember 12, 1980
K780150NEONATAL SCREENING AUDIOMETERFebruary 13, 1978