Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K772186 |
Device Name |
ELECTROCARDIOGRAPH TRANSMITTER, 536 |
Applicant |
INTERMEDICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
INTERMEDICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 11/25/1977 |
Decision Date | 02/02/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|