The following data is part of a premarket notification filed by Airsep Corp. with the FDA for 4lyf Oxygen Concentrator.
| Device ID | K872534 |
| 510k Number | K872534 |
| Device Name: | 4LYF OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | AIRSEP CORP. 84 AERO DR. Buffalo, NY 14225 |
| Contact | Peter Weisenborn |
| Correspondent | Peter Weisenborn AIRSEP CORP. 84 AERO DR. Buffalo, NY 14225 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-26 |
| Decision Date | 1987-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M766AS0987190 | K872534 | 000 |