The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Vti Oxygen Analyzer.
| Device ID | K922738 |
| 510k Number | K922738 |
| Device Name: | VTI OXYGEN ANALYZER |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED 25 INDUSTRIAL AVE. Chelmsford, MA 01824 |
| Contact | David L Regan |
| Correspondent | David L Regan 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 | 1992-06-08 |
| Decision Date | 1993-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817122020010 | K922738 | 000 |