EZSLEEP SLEEP QUALITY RECORDER


Device Classification Name

electrocardiograph,ambulatory(without analysis)

510(k) Number K112573
Device Name EZSLEEP SLEEP QUALITY RECORDER
Applicant
PLATINUM TEAM CO., LTD
396 daye road
taipai, 

TW

11268

Applicant Contact james ho
Correspondent
PLATINUM TEAM CO., LTD
396 daye road
taipai, 

TW

11268

Correspodent Contact james ho
Regulation Number 870.2800
Classification Product Code
MWJ  
Date Received 09/06/2011
Decision Date 03/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No