The following data is part of a premarket notification filed by Ventrex, Llc. with the FDA for Ventrex Oxygen Sensor.
| Device ID | K963415 |
| 510k Number | K963415 |
| Device Name: | VENTREX OXYGEN SENSOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | VENTREX, LLC. 159 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | Mary Huegel |
| Correspondent | Mary Huegel VENTREX, LLC. 159 GIBRALTAR RD. Horsham, PA 19044 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1996-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853061006722 | K963415 | 000 |
| 00853061006715 | K963415 | 000 |