The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Innersense Disposable Microtransducer.
| Device ID | K941283 |
| 510k Number | K941283 |
| Device Name: | INNERSENSE DISPOSABLE MICROTRANSDUCER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Charles J Welle |
| Correspondent | Charles J Welle BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-17 |
| Decision Date | 1994-04-19 |