GALEMED CPAP MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K072755
Device Name GALEMED CPAP MASK
Applicant
GALEMED CORP.
3460 pointe creek court
suite 102
bonita springs, 
FL 
34134 -2015

Applicant Contact paul dryden
Correspondent
GALEMED CORP.
3460 pointe creek court
suite 102
bonita springs, 
FL 
34134 -2015

Correspodent Contact paul dryden
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 09/27/2007
Decision Date 11/16/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No