Airsep Corp.
Medical device manufacturer in Buffalo, NY.
19510(k) clearances
0PMA approvals
0recalls
Device types
- CAW Generator, Oxygen, Portable 8
- CAF Nebulizer (Direct Patient Interface) 2
- NFB Conserver, Oxygen 2
- OLV Standard Polysomnograph With… 2
- BZD Ventilator, Non-Continuous (Respirator) 1
- FLS Monitor, Apnea, Facility Use 1
- GWE Stimulator, Photic, Evoked Response 1
- GWF Stimulator, Electrical, Evoked Response 1
- DQA Oximeter 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S)CAW · Traditional | 12/18/2015SE |
| K101154 | Centrox, Reliant, Ultrox, As-D+, As-E, As-G, As-J, As-K and As-LCAW · Traditional | 03/28/2011SE |
| K080348 | Oxiscan II Data Management SystemDQA · Traditional | 10/09/2008SE |
| K020324 | Lifestyle Oxygen ConcentratorCAW · Traditional | 03/13/2002SE |
| K012037 | Healthlife Oxygen Concentrator Model AS009CAW · Traditional | 01/17/2002SE |
| K000963 | Da Vinchi EEG and Emg/Ep SystemsGWF · Traditional | 10/20/2000SE |
| K001579 | Impulse SelectNFB · Traditional | 08/31/2000SE |
| K001467 | Da Vinchi Emg/Ep ISA1004EPGWE · Traditional | 08/01/2000SE |
| K001013 | Monet Acquisition System for EEG and PolysomnographyOLV · Traditional | 05/16/2000SE |
| K992283 | Artisan Acquisition System for EEG and PolysomnographyOLV · Traditional | 08/27/1999SE |
| K983002 | Mystique Ultrasonic NebulizerCAF · Traditional | 10/16/1998SE |
| K960309 | Airsep Newlife Dual Six Oxygen Concentrator (Modification)CAW · Traditional | 02/28/1997SE |
| K962865 | Rembrandt SystemFLS · Traditional | 10/25/1996ST |
| K962766 | Airsep ImpulseNFB · Traditional | 10/10/1996SE |
| K943207 | Nitelife Bi-Level CPAPBZD · Traditional | 07/29/1996SE |
| K951882 | Eco Check (Ecovalve and Oxygen Monitor)CAW · Traditional | 10/16/1995SE |
| K944020 | Airsep Newlife Air Outlet OptionCAF · Traditional | 03/16/1995SE |
| K884581 | Reliant Oxygen ConcentratorCAW · Traditional | 01/11/1989SE |
| K872534 | 4LYF Oxygen ConcentratorCAW · Traditional | 10/13/1987SE |