The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Hr Unit.
| Device ID | K782148 |
| 510k Number | K782148 |
| Device Name: | HR UNIT |
| Classification | Rotator, Transverse |
| Applicant | PARKE-DAVIS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IQP |
| CFR Regulation Number | 890.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-22 |
| Decision Date | 1979-01-08 |