H2 HEATED HUMIDIFIER


Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K030090
Device Name H2 HEATED HUMIDIFIER
Original Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Original Contact zita a yurko
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 01/10/2003
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No