MOBILEECG SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K103427
Device Name MOBILEECG SYSTEM
Applicant
MEMTEC CORP.
68 stiles rd. unit d
salem, 
NH 
03079

Applicant Contact dennis garboski
Correspondent
MEMTEC CORP.
68 stiles rd. unit d
salem, 
NH 
03079

Correspodent Contact dennis garboski
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 11/22/2010
Decision Date 03/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No