Device Classification Name |
incubator, neonatal
|
510(k) Number |
K801461 |
Device Name |
THERMA-SHIELD |
Applicant |
OLYMPIC MEDICAL CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
OLYMPIC MEDICAL CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.5400
|
Classification Product Code |
|
Date Received | 06/24/1980 |
Decision Date | 07/28/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|