The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Vascular Technology Uniox Oxygen Alarm.
| Device ID | K890058 |
| 510k Number | K890058 |
| Device Name: | VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED 25 INDUSTRIAL AVE. Chelmsford, MA 01824 |
| Contact | William R Oliver |
| Correspondent | William R Oliver VASCULAR TECHNOLOGY INCORPORATED 25 INDUSTRIAL AVE. Chelmsford, MA 01824 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-06 |
| Decision Date | 1989-11-21 |