Device Classification Name |
Encephalogram Telemetry System
|
510(k) Number |
K970659 |
Device Name |
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER |
Applicant |
TELEDIAGNOSTIC SYSTEMS, INC. |
2053 SUTTER ST. |
SAN FRANCISCO,
CA
94115
|
|
Applicant Contact |
LARRY WOODARD |
Correspondent |
TELEDIAGNOSTIC SYSTEMS, INC. |
2053 SUTTER ST. |
SAN FRANCISCO,
CA
94115
|
|
Correspondent Contact |
LARRY WOODARD |
Regulation Number | 882.1855
|
Classification Product Code |
|
Date Received | 02/21/1997 |
Decision Date | 05/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|