Device Classification Name |
synchronizer, electrocardiograph, nuclear
|
510(k) Number |
K790213 |
Device Name |
GENERATOR, R-WAVE |
Applicant |
AMR CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMR CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1410
|
Classification Product Code |
|
Date Received | 01/30/1979 |
Decision Date | 03/22/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|