The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Bentley Theromodilution Catheter #btd-7f.
| Device ID | K802133 |
| 510k Number | K802133 |
| Device Name: | BENTLEY THEROMODILUTION CATHETER #BTD-7F |
| Classification | Probe, Thermodilution |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-04 |
| Decision Date | 1980-09-26 |