Clearance Summary
HR UNIT received FDA 510(k) clearance under submission number K782148, sponsored by Parke-Davis Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1979-01-08.
- Submission: K782148
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1979-01-08
Classification & Regulation
This clearance is catalogued under FDA product code IQP and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.