Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921
FDA 510(k) K052743 · Dynarex Corp.
510(k) numberK052743
Submission
- Device name
- Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921
- Applicant
- Dynarex Corp.
Orangeburg, NY, US - Received
- September 30, 2005
- Decision date
- December 22, 2005
- 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
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| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb)CBP · Traditional | Meditera Tibbi Malzeme San VE Tic AS | 12/23/2021SE |
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| 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 |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen PortCBP · Traditional | Hangzhou Jinlin Medical Appliances Co., Ltd. | 07/09/2015SE |
| K142402 | BigEasy Non-Rebreathing ValveCBP · Traditional | 12th Man Technologies, Inc. | 03/23/2015SE |
| K132143 | Exhalation ValveCBP · Traditional | Intersurgical Incorporated | 06/04/2014SE |
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Questions and answers
When was Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921 cleared by the FDA?
Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921 (K052743) received a 510(k) decision of Substantially Equivalent on December 22, 2005, 83 days after the submission was received.
What is the product code of K052743?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.