LAMIN AIR


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K080516
Device Name LAMIN AIR
Applicant
REMGENIC LLC
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
REMGENIC LLC
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 02/25/2008
Decision Date 06/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No