ERKA. PERFECT-ANEROID


Device Classification Name

blood pressure cuff

510(k) Number K103637
Device Name ERKA. PERFECT-ANEROID
Applicant
ERKA KALLMEYER MEDIZINTECHNIK GMBH
im farchet 15
bad toelz, bavaria, 

DE

83646

Applicant Contact jan weiss
Regulation Number 870.1120
Classification Product Code
DXQ  
Date Received 12/13/2010
Decision Date 06/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No