The following data is part of a premarket notification filed by Oxytec Medical Corporation with the FDA for Oxytec, Model 900.
| Device ID | K043615 |
| 510k Number | K043615 |
| Device Name: | OXYTEC, MODEL 900 |
| Classification | Generator, Oxygen, Portable |
| Applicant | OXYTEC MEDICAL CORPORATION 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden OXYTEC MEDICAL CORPORATION 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-30 |
| Decision Date | 2005-02-09 |
| Summary: | summary |