ALERKAN SPIROMETRY FILTER


Device Classification Name

spirometer, diagnostic

510(k) Number K111587
Device Name ALERKAN SPIROMETRY FILTER
Applicant
ALERKAN LTD
1340 west pennsylvania ave.
san diego, 
CA 
92013

Applicant Contact glen feye
Correspondent
ALERKAN LTD
1340 west pennsylvania ave.
san diego, 
CA 
92013

Correspodent Contact glen feye
Regulation Number 868.1840
Classification Product Code
BZG  
Date Received 06/07/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No