Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K951370 |
Device Name |
ZYMED TELEMETRY SYSTEM; MODEL T8010 |
Applicant |
ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. |
CAMARILLO,
CA
93010
|
|
Applicant Contact |
J. D HARRIS |
Correspondent |
ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. |
CAMARILLO,
CA
93010
|
|
Correspondent Contact |
J. D HARRIS |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/27/1995 |
Decision Date | 10/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|