STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002


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

Correspodent Contact roger t vaughan
Regulation Number 880.6760
Classification Product Code
FMQ  
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