ISOLETTE INFANT INCUBATOR, MODEL C2HS


Device Classification Name

incubator, neonatal

510(k) Number K001242
Device Name ISOLETTE INFANT INCUBATOR, MODEL C2HS
Original Applicant
HILL-ROM AIR-SHIELDS
330 jacksonville rd.
hatboro, 
PA 
19040

Original Contact james g carpenter
Regulation Number 880.5400
Classification Product Code
FMZ  
Date Received 04/18/2000
Decision Date 07/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No