510(k) K142764

KYOLING CPR Mask with Oxygen Port and Without Oxygen Port by Hangzhou Jinlin Medical Appliances Co., Ltd. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2015
Date Received
September 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type