510(k) K203209
- Device
- AirPhysio Positive Expiratory (PEP) Device
- Applicant
- AirPhysio Pty Ltd
- 510(k) number
- K203209
- Product code
- BWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-15
- Date received
- 2020-10-30
- Regulation
- 868.5690
- Classification name
- Spirometer, Therapeutic (incentive)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Paul O’Brien
- Address
- Unit 1, 43 Greenway Dr. Tweed Heads South AU NSW 2486 NSW 2486
FDA Registration Numbers#
- 1937060
- 1832562
- 3023272766
- 1649518
- 3007309299
- 1024404
- 2183816
- 3003589956
- 3011120183
- 3006087789
- 3012307300
- 3004961434
- 8044169
- 3010009632
- 2029275
- 1314417
- 3008145987
- 9610639
- 3023531666
- 3008008970
- 2022691
- 3004183730
- 3021235837
- 1526863
- 2134852
- 2026894
- 1643817
- 8021995
- 3011270181
- 3035523355
- 8030647
- 3000126629
- 3018783526
- 2032098
- 3006666710
Source Documents#
Other 510(k) Records For Product Code BWF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241152 | InSee | Tidal Medical Technologies, LLC | 2025-08-21 |
| K233855 | AllPEP | Enchant Tek Co. , Ltd. | 2024-02-02 |
| K221058 | LungTrainer (MD2 & MD3) | Lung Trainers, LLC | 2023-07-05 |
| K222018 | Breathe+ | Peep Medical, LLC Dba Go2 Devices | 2023-06-02 |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | 2022-10-25 |
| K203378 | Pulsehaler | Respinova, Ltd. | 2021-03-31 |
| K192000 | D R Burton OxyPAP | D R Burton Healthcare, LLC | 2020-02-19 |
| K181660 | Acapella Choice Blue Vibratory PEP Device | Smiths Medical | 2019-10-24 |
| K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019-08-16 |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | 2019-07-01 |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | 2018-08-17 |
| K172388 | VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017-12-22 |
| K160837 | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM | Medinet Srl | 2017-02-23 |
| K163091 | VibraPEP | Medica Holdings, LLC | 2017-02-21 |
| K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | 2016-08-03 |
Legacy Summary#
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FDA Review#
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