The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Lifestyle Oxygen Concentrator.
| Device ID | K020324 |
| 510k Number | K020324 |
| Device Name: | LIFESTYLE OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | Charlotte H Hamilton |
| Correspondent | Charlotte H Hamilton AIRSEP CORP. 290 CREEKSIDE DR. 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 | 2002-01-31 |
| Decision Date | 2002-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M766AS2002010 | K020324 | 000 |
| M766AS2001DTC0 | K020324 | 000 |
| M766AS2001010 | K020324 | 000 |
| M766AS20010 | K020324 | 000 |
| M766AS0951010 | K020324 | 000 |
| M766AS077101CU0 | K020324 | 000 |
| M766AS20060 | K020324 | 000 |
| M766AS2002060 | K020324 | 000 |
| M766AS2001060 | K020324 | 000 |