3B FLEX-LITE


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K103434
Device Name 3B FLEX-LITE
Applicant
3B PRODUCTS, LLC
1142 n scenic highway
lake wales, 
FL 
33853

Applicant Contact albert alexander lucio
Correspondent
3B PRODUCTS, LLC
1142 n scenic highway
lake wales, 
FL 
33853

Correspodent Contact albert alexander lucio
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 11/23/2010
Decision Date 10/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No