RESPIFIT S, MODEL RS-LR1001004


Device Classification Name

spirometer, therapeutic (incentive)

510(k) Number K080299
Device Name RESPIFIT S, MODEL RS-LR1001004
Applicant
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH
1341 w fullerton
suite 103
chicago, 
IL 
60014

Applicant Contact david levine
Correspondent
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH
1341 w fullerton
suite 103
chicago, 
IL 
60014

Correspodent Contact david levine
Regulation Number 868.5690
Classification Product Code
BWF  
Date Received 02/05/2008
Decision Date 01/13/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No