KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
FDA 510(k) K142764 · Hangzhou Jinlin Medical Appliances Co., Ltd.
510(k) numberK142764
Submission
- Device name
- KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
- Applicant
- Hangzhou Jinlin Medical Appliances Co., Ltd.
Hangzhou, CN - Received
- September 25, 2014
- Decision date
- July 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBP – Valve, Non-Rebreathing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5870
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)CBP · Traditional | Dehas Medical Systems GmbH | 10/29/2024SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/09/2024SE |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb)CBP · Traditional | Meditera Tibbi Malzeme San VE Tic AS | 12/23/2021SE |
| K192285 | CPR Face ShieldCBP · Traditional | Firstar Healthcare Company Limited (Guangzhou) | 11/25/2020SE |
| K173770 | OJR215 Pressure Relief ManifoldCBP · Traditional | Fisher & Paykel Healthcare Limited | 04/05/2019SE |
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…CBP · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 11/17/2017SE |
| K152521 | Seal Rite Non-Rebreathing ValveCBP · Traditional | The Lifeguard Store, Inc. | 06/03/2016SE |
| K142402 | BigEasy Non-Rebreathing ValveCBP · Traditional | 12th Man Technologies, Inc. | 03/23/2015SE |
| K132143 | Exhalation ValveCBP · Traditional | Intersurgical Incorporated | 06/04/2014SE |
| K112126 | Genuine First Aid CPR MaskCBP · Traditional | Genuine First Aid, LLC | 12/01/2011SE |
Questions and answers
When was KYOLING CPR Mask with Oxygen Port and Without Oxygen Port cleared by the FDA?
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (K142764) received a 510(k) decision of Substantially Equivalent on July 9, 2015, 287 days after the submission was received.
What is the product code of K142764?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.