SPIRO-MASTER PC-10 SPIROMETRY SYSTEM


Device Classification Name

spirometer, diagnostic

510(k) Number K080921
Device Name SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
Applicant
CHEST M.I., INC.
4-2-1 yushima, bunkyo-ku
tokyo, 

JP

113-0034

Applicant Contact fumiaki kanai
Correspondent
CHEST M.I., INC.
4-2-1 yushima, bunkyo-ku
tokyo, 

JP

113-0034

Correspodent Contact fumiaki kanai
Regulation Number 868.1840
Classification Product Code
BZG  
Date Received 04/01/2008
Decision Date 01/21/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No