The following data is part of a premarket notification filed by Burke, Inc. with the FDA for Pacesaver & Scout.
| Device ID | K834506 |
| 510k Number | K834506 |
| Device Name: | PACESAVER & SCOUT |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | BURKE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-01-30 |