QHRV 1 – HEALTH ASSESSMENT SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K080884
Device Name QHRV 1 – HEALTH ASSESSMENT SYSTEM
Applicant
MEDTECHS, LLC
111 beaver dam run
durhan, 
NC 
27703

Applicant Contact meghan ath
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 03/31/2008
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No