PROVOX MICRON HME


Device Classification Name

tube tracheostomy and tube cuff

510(k) Number K072582
Device Name PROVOX MICRON HME
Applicant
ATOS MEDICAL AB
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
ATOS MEDICAL AB
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5800
Classification Product Code
JOH  
Date Received 09/13/2007
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No