PARI HYDRATE V


Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K072982
Device Name PARI HYDRATE V
Applicant
PARI INNOVATIVE MANUFACTURERS, INC.
2943 oaklake blvd.
midlothian, 
VA 
23112

Applicant Contact mike judge
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 10/23/2007
Decision Date 11/29/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No