The following data is part of a premarket notification filed by Airsep Corporation with the FDA for Deployable Oxygen Generation System-smaill (dogs-s).
| Device ID | K150930 |
| 510k Number | K150930 |
| Device Name: | Deployable Oxygen Generation System-Smaill (DOGS-S) |
| Classification | Generator, Oxygen, Portable |
| Applicant | AirSep Corporation 260 Creekside Drive Buffalo, NY 14228 |
| Contact | Peter Weisenborn |
| Correspondent | Ted Vlahopoulos AirSep Corporation 260 Creekside Drive Buffalo, NY 14228 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M766AS00710 | K150930 | 000 |