PHYSIOGLOVE ES WITH ECG ANALYSIS


Device Classification Name

electrocardiograph

510(k) Number K103791
Device Name PHYSIOGLOVE ES WITH ECG ANALYSIS
Applicant
COMMWELL LTD.
rechov yad harutzim 4
kfar saba, 

IL

44641

Applicant Contact irving levy
Correspondent
COMMWELL LTD.
rechov yad harutzim 4
kfar saba, 

IL

44641

Correspodent Contact irving levy
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 12/27/2010
Decision Date 10/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No