Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K924187 |
Device Name |
INSTANT MEMORY 2000 |
Applicant |
TELESCAN MEDICAL SYSTEMS |
10091 STREETER RD. |
AUBURN,
CA
95003
|
|
Applicant Contact |
STANLEY WAGNER |
Correspondent |
TELESCAN MEDICAL SYSTEMS |
10091 STREETER RD. |
AUBURN,
CA
95003
|
|
Correspondent Contact |
STANLEY WAGNER |
Regulation Number | 870.2920 |
Classification Product Code |
|
Date Received | 08/20/1992 |
Decision Date | 06/16/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|