Device Classification Name |
system, thermal regulating
|
510(k) Number |
K811742 |
FOIA Releasable 510(k) |
K811742
|
Device Name |
HEMOTHERM MODEL 400 |
Applicant |
CINCINNATI SUB-ZERO |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CINCINNATI SUB-ZERO |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 06/19/1981 |
Decision Date | 08/13/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|