The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Bk-7497 Bulb Dynamometer.
| Device ID | K801715 |
| 510k Number | K801715 |
| Device Name: | BK-7497 BULB DYNAMOMETER |
| Classification | Goniometer, Nonpowered |
| Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQW |
| CFR Regulation Number | 888.1520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-24 |
| Decision Date | 1980-08-04 |