PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES


Device Classification Name

attachment, breathing, positive end expiratory pressure

510(k) Number K122610
Device Name PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
Applicant
SEN MU TECHNOLOGY CO., LTD.
no. 15-2, lane 26, mincyuan 1sr rd
lingya district
kaohsiung city, 

TW

802

Applicant Contact ming-yie jn, ph.d.
Correspondent
SEN MU TECHNOLOGY CO., LTD.
no. 15-2, lane 26, mincyuan 1sr rd
lingya district
kaohsiung city, 

TW

802

Correspodent Contact ming-yie jn, ph.d.
Regulation Number 868.5965
Classification Product Code
BYE  
Date Received 08/27/2012
Decision Date 08/05/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No