V-2100G ADVANCED INFANT INCUBATOR


Device Classification Name

incubator, neonatal

510(k) Number K021809
Device Name V-2100G ADVANCED INFANT INCUBATOR
Original Applicant
ATOM MEDICAL CORP.
49 plain st.
north attleboro, 
MA 
02760

Original Contact sheila hemeon-heyer
Regulation Number 880.5400
Classification Product Code
FMZ  
Date Received 06/03/2002
Decision Date 07/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No