The following data is part of a premarket notification filed by American Bentley with the FDA for Bp Transducer Holders Th-2,3 & 4.
| Device ID | K832384 |
| 510k Number | K832384 |
| Device Name: | BP TRANSDUCER HOLDERS TH-2,3 & 4 |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | AMERICAN BENTLEY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-19 |
| Decision Date | 1983-11-14 |