The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Portable Oxygen Generator.
| Device ID | K915381 |
| 510k Number | K915381 |
| Device Name: | PORTABLE OXYGEN GENERATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Kenneth Harland |
| Correspondent | Kenneth Harland AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-03-11 |