Device Classification Name |
restraint, protective
|
510(k) Number |
K081264 |
Device Name |
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 |
Applicant |
CHILDREN'S HEALTH FIRST, INC. |
5249 SHELLEY PLACE |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
ROGER T VAUGHAN |
Correspondent |
CHILDREN'S HEALTH FIRST, INC. |
5249 SHELLEY PLACE |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
ROGER T VAUGHAN |
Regulation Number | 880.6760
|
Classification Product Code |
|
Date Received | 05/05/2008 |
Decision Date | 02/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|