SPIRODOC


Device Classification Name

spirometer, diagnostic

510(k) Number K103530
Device Name SPIRODOC
Applicant
MEDICAL INTERNATIONAL RESEARCH USA, INC.
1900 pewaukee road
suite o
waukesha, 
WI 
53188

Applicant Contact ed kohere
Correspondent
MEDICAL INTERNATIONAL RESEARCH USA, INC.
1900 pewaukee road
suite o
waukesha, 
WI 
53188

Correspodent Contact ed kohere
Regulation Number 868.1840
Classification Product Code
BZG  
Subsequent Product Code
DQA  
Date Received 12/01/2010
Decision Date 11/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No