The following data is part of a premarket notification filed by American Bentley with the FDA for Bentley-trantec Dispos. Domes D-260-.
| Device ID | K841811 |
| 510k Number | K841811 |
| Device Name: | BENTLEY-TRANTEC DISPOS. DOMES D-260- |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | AMERICAN BENTLEY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-01 |
| Decision Date | 1985-09-09 |