Company ยท US
Airsep Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2015. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAW | Generator, Oxygen, Portable | 8 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| NFB | Conserver, Oxygen | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| DQA | Oximeter | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2015 | K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) Airsep Corporation | CAW |
| Mar 28, 2011 | K101154 | CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L Airsep Corp. | CAW |
| Oct 9, 2008 | K080348 | OXISCAN II DATA MANAGEMENT SYSTEM Airsep Corp. | DQA |
| Mar 13, 2002 | K020324 | LIFESTYLE OXYGEN CONCENTRATOR Airsep Corp. | CAW |
| Jan 17, 2002 | K012037 | HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 Airsep Corp. | CAW |
| Oct 20, 2000 | K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS Airsep Corp. | GWF |
| Aug 31, 2000 | K001579 | IMPULSE SELECT Airsep Corp. | NFB |
| Aug 1, 2000 | K001467 | DA VINCHI EMG/EP ISA1004EP Airsep Corp. | GWE |
| May 16, 2000 | K001013 | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY Airsep Corp. | OLV |
| Aug 27, 1999 | K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY Airsep Corp. | OLV |
| Oct 16, 1998 | K983002 | MYSTIQUE ULTRASONIC NEBULIZER Airsep Corp. | CAF |
| Feb 28, 1997 | K960309 | AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) Airsep Corp. | CAW |
| Oct 25, 1996 | K962865 | REMBRANDT SYSTEM Airsep Corp. | FLS |
| Oct 10, 1996 | K962766 | AIRSEP IMPULSE Airsep Corp. | NFB |
| Jul 29, 1996 | K943207 | NITELIFE BI-LEVEL CPAP Airsep Corp. | BZD |
| Oct 16, 1995 | K951882 | ECO CHECK (ECOVALVE AND OXYGEN MONITOR) Airsep Corp. | CAW |
| Mar 16, 1995 | K944020 | AIRSEP NEWLIFE AIR OUTLET OPTION Airsep Corp. | CAF |
| Jan 11, 1989 | K884581 | RELIANT OXYGEN CONCENTRATOR Airsep Corp. | CAW |
| Oct 13, 1987 | K872534 | 4LYF OXYGEN CONCENTRATOR Airsep Corp. | CAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||