510(k) K241366
- Device
- QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
- Applicant
- Dehas Medical Systems GmbH
- 510(k) number
- K241366
- Product code
- CBP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-29
- Date received
- 2024-05-14
- Regulation
- 868.5870
- Classification name
- Valve, Non-Rebreathing
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jens Mittendorf
- Address
- Wesloer Straße 107-109 Luebeck DE 23568 23568
FDA Registration Numbers#
- 3008264111
- 3008384335
- 3008261717
- 9710391
- 2518436
- 3014126909
- 3001313714
- 9710644
- 3006534321
- 2022648
- 3013226
- 9616567
- 3005621729
- 3003674698
- 3015191173
- 3030455652
- 9610861
- 3016450032
- 8043316
- 3006783791
- 2020676
- 3012711490
- 3017406698
- 3004993040
- 3025413691
- 3015745029
- 9681409
- 3004056932
- 3021039857
- 3011647251
- 3001106688
- 3012762174
- 3001204077
- 9612374
- 3011767915
- 3005587132
- 2028807
- 3010402691
- 3009512503
- 2085602
- 3003887292
- 1250045
- 3015781296
- 3010934856
- 3031288561
- 2030745
- 3020777588
- 9681848
- 1025972
- 9611451
- 3015422337
- 8030673
- 2431014
- 3012307300
- 3006157842
- 3011137372
- 3011529314
- 9616354
- 3020460367
- 3014527907
- 3003902679
- 3002807267
- 1924066
- 1314417
- 2183615
- 3010452651
- 3012034017
- 3011185837
- 3004365956
- 1526863
Source Documents#
Other 510(k) Records For Product Code CBP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234053 | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | 2021-12-23 |
| K192285 | CPR Face Shield | Firstar Healthcare Company Limited (Guangzhou) | 2020-11-25 |
| K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | 2019-04-05 |
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) | Xiamen Compower Medical Tech. Co., Ltd. | 2017-11-17 |
| K152521 | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | 2016-06-03 |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | 2015-07-09 |
| K142402 | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | 2015-03-23 |
| K132143 | EXHALATION VALVE | Intersurgical Incorporated | 2014-06-04 |
| K112126 | GENUINE FIRST AID CPR MASK | Genuine First Aid, LLC | 2011-12-01 |
| K111191 | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | Wet Nose Technologies, LLC | 2011-07-28 |
| K102299 | CPR FACE MASK | Genuine First Aid, LLC | 2011-03-18 |
| K083418 | CPR MASK | Firstar Healthcare Co., Ltd. | 2010-07-22 |
| K091538 | PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 | Wet Nose Technologies, LLC | 2010-03-25 |
| K082345 | OXYGEN DEMAND VALVE | Bpr Medical, Ltd. | 2009-03-13 |