| K-number | K945754 |
| Device name | NEWOX2 |
| Applicant | Bci Intl., Inc. |
| Product code | DQA |
| Device class | Class II |
| Decision date | Jul 17, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 870.2700 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov