The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Lifechoice Oxygen Concentrator, Model Oxy1000.
| Device ID | K072688 |
| 510k Number | K072688 |
| Device Name: | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 |
| Classification | Generator, Oxygen, Portable |
| Applicant | INTERNATIONAL BIOPHYSICS CORP. 2101-2 E. ST. ELMO SUITE 275 Austin, TX 78744 |
| Contact | David Shockley |
| Correspondent | David Shockley INTERNATIONAL BIOPHYSICS CORP. 2101-2 E. ST. ELMO SUITE 275 Austin, TX 78744 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-24 |
| Decision Date | 2008-01-11 |
| Summary: | summary |