HEALTH MANAGER, VERSION 1.1


Device Classification Name

transmitters and receivers, physiological signal, radiofrequency

510(k) Number K081499
Device Name HEALTH MANAGER, VERSION 1.1
Applicant
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
bernhaeuser strasse 17
neuhausen a.d.f., 

DE

73765

Applicant Contact marion otto
Correspondent
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
bernhaeuser strasse 17
neuhausen a.d.f., 

DE

73765

Correspodent Contact marion otto
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 05/29/2008
Decision Date 01/16/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No