RAPHAEL


Device Classification Name

ventilator, continuous, facility use

510(k) Number K022679
Device Name RAPHAEL
Original Applicant
HAMILTON MEDICAL AG
p.o. box 30008 (89520)
4990 energy way
reno, 
NV 
89502

Original Contact david thompson
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 08/12/2002
Decision Date 10/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls