Device Classification Name |
electrocardiograph
|
510(k) Number |
K946205 |
Device Name |
CARDIOVIT AT-1, P-80 |
Applicant |
SCHILLER AMERICA, INC. |
3002 DOW AVE., #138 |
TUSTIN,
CA
92780
|
|
Applicant Contact |
MARKUA MARTITZ |
Correspondent |
SCHILLER AMERICA, INC. |
3002 DOW AVE., #138 |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
MARKUA MARTITZ |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 12/21/1994 |
Decision Date | 03/16/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|