Product code BXP
- Device name
- Transducer, Gas Flow
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.2885
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K936141 | UNIPOWER RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-03-31 |
| K920360 | TIMOX OXYGEN TIMER | Medical Fittings, Inc. | 1992-08-03 |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Kells Medical, Inc. | 1984-03-07 |
| K800087 | ULTRASONIC FLOWMETER | The Perkin-Elmer Corp. | 1980-03-19 |
| K781039 | OXY-ON DIGITAL OXYGEN TIMER | Chambers & Sadler Mfg. | 1978-08-31 |
| K770424 | OXYGEN TWMER, MODEL SST | Timeter Instrument Corp. | 1977-03-16 |
| K761260 | ARIZONA OXYGEN TIMER DEVICE | The John Bunn Co. | 1976-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884838105584 | Flow Sensor | Respironics Novametrix, LLC | 2023-11-15 |
| 00884838105607 | Flow Sensor | Respironics Novametrix, LLC | 2023-11-15 |
| 30884838105585 | Respironics | Respironics Novametrix, LLC | 2023-11-15 |
| 30884838105608 | Respironics | Respironics Novametrix, LLC | 2023-11-15 |
| 07640142190479 | Spiro-SP TrueFlow Sensor | NDD Medizintechnik AG | 2023-06-23 |
| 20884521210933 | Puritan Bennett | Covidien LP | 2023-02-03 |
| 10884521210936 | Puritan Bennett | Covidien LP | 2023-02-03 |
| 04048675448938 | Infinity ID Flow Sensor | Drägerwerk AG & Co. KGaA | 2022-04-08 |
| 04048675448860 | Spirolog Flow Sensor | Drägerwerk AG & Co. KGaA | 2022-04-08 |
| 04048675448853 | Neonatal flow sensor insert | Drägerwerk AG & Co. KGaA | 2022-04-08 |
| 04048675000099 | Neonatal flow sensor ISO15 | Drägerwerk AG & Co. KGaA | 2022-04-08 |
| 04048675005612 | SpiroLife | Drägerwerk AG & Co. KGaA | 2022-04-08 |
| 20884521139852 | Puritan Bennett | Covidien LP | 2021-04-15 |
| 10884521139855 | Puritan Bennett | Covidien LP | 2021-04-15 |
| 00884838014145 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 00884838014374 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 00884838014367 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 00884838014350 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 00884838014152 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 00884838014138 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 00884838014121 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 00884838014114 | Flow Sensor | Respironics Novametrix, LLC | 2020-09-14 |
| 06944904096766 | Respiratory Mech mod,w/accssry | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-07 |
| 06420099000554 | M9256, SpiroSafe Disposable Flow Transducer | Medikro Oy | 2018-07-13 |
| 06420099000561 | M9256, SpiroSafe Disposable Flow Transducer | Medikro Oy | 2018-07-13 |
| 04036616001809 | Flow sensor | Honeywell Healthcare Solutions GmbH | 2016-09-22 |
| 04049098007740 | Respiratory Mechanics Flow Sensor – Adult/Pediatric | DRAEGER MEDICAL SYSTEMS, INC. | 2015-11-02 |