Airsep Impulse
FDA 510(k) K962766 · Airsep Corp.
510(k) numberK962766
Submission
- Device name
- Airsep Impulse
- Applicant
- Airsep Corp.
Buffalo, NY, US - Received
- July 16, 1996
- Decision date
- October 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NFB – Conserver, Oxygen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K131023 | Theraflow Single Lumen and Theraflow Dual LumenNFB · Traditional | Medical Products, LLC | 10/11/2013SE |
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | Inovo, Inc. | 12/08/2011SE |
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| K090421 | Model 350G Gas ConserverNFB · Traditional | Inspired Technologies, Inc. | 05/29/2009SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | Chad Therapeutics, Inc. | 05/07/2007SE |
More from Chad Therapeutics, Inc.
| 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 |
Questions and answers
When was Airsep Impulse cleared by the FDA?
Airsep Impulse (K962766) received a 510(k) decision of Substantially Equivalent on October 10, 1996, 86 days after the submission was received.
What is the product code of K962766?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.