WESTMED, INC.’S BLOCKAIDE FILTER [21 CFR 807.87(A)]


Device Classification Name

filter, bacterial, breathing-circuit

510(k) Number K121382
Device Name WESTMED, INC.’S BLOCKAIDE FILTER [21 CFR 807.87(A)]
Applicant
Westmed, Inc.
5580 s. nogales highway
tucson, 
AZ 
85706

Applicant Contact r. john mckinnon
Correspondent
Westmed, Inc.
5580 s. nogales highway
tucson, 
AZ 
85706

Correspodent Contact r. john mckinnon
Regulation Number 868.5260
Classification Product Code
CAH  
Date Received 05/08/2012
Decision Date 12/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No