TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K081498
Device Name TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
Applicant
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
bernhaeuser strasse 17
neuhausen a.d.f., 

DE

73765

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

DE

73765

Correspodent Contact martin gabler
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 05/29/2008
Decision Date 12/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No