MINIME 2 NASAL MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K121692
Device Name MINIME 2 NASAL MASK
Applicant
SLEEPNET CORPORATION
24301 woodsage drive
bonita springs, 
FL 
34134 -2958

Applicant Contact paul dryden
Correspondent
SLEEPNET CORPORATION
24301 woodsage drive
bonita springs, 
FL 
34134 -2958

Correspodent Contact paul dryden
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 06/07/2012
Decision Date 11/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No