CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)


Device Classification Name

ventilator, emergency, powered (resuscitator)

510(k) Number K081330
Device Name CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
Applicant
O-TWO MEDICAL TECHNOLOGIES, INC.
24301 woodsage drive
bonita springs, 
FL 
34134 -2958

Applicant Contact paul dryden
Correspondent
O-TWO MEDICAL TECHNOLOGIES, INC.
24301 woodsage drive
bonita springs, 
FL 
34134 -2958

Correspodent Contact paul dryden
Regulation Number 868.5925
Classification Product Code
BTL  
Date Received 05/12/2008
Decision Date 03/06/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No