Home / 510(k) Clearances / K142764

510(k) K142764

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

K142764 is an FDA 510(k) premarket notification submitted by Hangzhou Jinlin Medical Appliances Co., Ltd. for the device "KYOLING CPR Mask with Oxygen Port and Without Oxygen Port". The FDA issued a decision of Substantially Equivalent on July 9, 2015. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870.

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

Other clearances for product code CBP

  • K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MT (October 29, 2024)
  • K234053 — F&P Optiflow Flow Diverter (August 9, 2024)
  • K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb) (December 23, 2021)
  • K192285 — CPR Face Shield (November 25, 2020)
  • K173770 — OJR215 Pressure Relief Manifold (April 5, 2019)
  • K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo (November 17, 2017)
  • K152521 — Seal Rite Non-Rebreathing Valve (June 3, 2016)
  • K142402 — BigEasy Non-Rebreathing Valve (March 23, 2015)
  • K132143 — EXHALATION VALVE (June 4, 2014)
  • K112126 — GENUINE FIRST AID CPR MASK (December 1, 2011)

FDA data resources