The following data is part of a premarket notification filed by Inovo, Inc. with the FDA for Purefill Oxygen Compressor.
| Device ID | K141967 |
| 510k Number | K141967 |
| Device Name: | PUREFILL OXYGEN COMPRESSOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | INOVO, INC. 401 Leonard Blvd N Lehigh Acres, FL 33971 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden INOVO, INC. 401 Leonard Blvd N Lehigh Acres, FL 33971 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-21 |
| Decision Date | 2014-11-07 |
| Summary: | summary |