Device Classification Name |
warmer, infant radiant
|
510(k) Number |
K850069 |
Device Name |
BORNING NEONATAL RESUSCITATOIN CENTER |
Applicant |
BORNING CORP. |
SOUTH 161 ADAMS |
SPOKANE,
WA
99204
|
|
Applicant Contact |
LOEL FENWICK |
Correspondent |
BORNING CORP. |
SOUTH 161 ADAMS |
SPOKANE,
WA
99204
|
|
Correspondent Contact |
LOEL FENWICK |
Regulation Number | 880.5130
|
Classification Product Code |
|
Date Received | 01/03/1985 |
Decision Date | 05/30/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|