CBP — Valve, Non-Rebreathing Class II
FDA Device Classification
Classification Details
- Product Code
- CBP
- Device Class
- Class II
- Regulation Number
- 868.5870
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K241366 | dehas medical systems | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MT | October 29, 2024 |
| K234053 | fisher and paykel healthcare | F&P Optiflow Flow Diverter | August 9, 2024 |
| K210992 | meditera tibbi malzeme san ve tic | Altech® Exhalation Valve (Single Limb and Dual Limb) | December 23, 2021 |
| K192285 | firstar healthcare company limited (guangzhou) | CPR Face Shield | November 25, 2020 |
| K173770 | fisher and paykel healthcare limited | OJR215 Pressure Relief Manifold | April 5, 2019 |
| K171961 | xiamen compower medical tech. co | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo | November 17, 2017 |
| K152521 | lifeguard store | Seal Rite Non-Rebreathing Valve | June 3, 2016 |
| K142764 | hangzhou jinlin medical appliances co | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | July 9, 2015 |
| K142402 | 12th man technologies | BigEasy Non-Rebreathing Valve | March 23, 2015 |
| K132143 | intersurgical incorporated | EXHALATION VALVE | June 4, 2014 |
| K112126 | genuine first aid | GENUINE FIRST AID CPR MASK | December 1, 2011 |
| K111191 | wet nose technologies | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | July 28, 2011 |
| K102299 | genuine first aid | CPR FACE MASK | March 18, 2011 |
| K083418 | firstar healthcare co | CPR MASK | July 22, 2010 |
| K091538 | wet nose technologies | PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV | March 25, 2010 |
| K082345 | bpr medical | OXYGEN DEMAND VALVE | March 13, 2009 |
| K081516 | medsource international | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | August 26, 2008 |
| K052458 | liv medica products pvt. | LIV MEDICA CPR FACE MASK | July 7, 2006 |
| K052743 | dynarex | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | December 22, 2005 |
| K042727 | foremount ent. co | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A | March 18, 2005 |