Clearance Summary
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG received FDA 510(k) clearance under submission number K801719, sponsored by Fred Sammons, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1980-08-04.
- Submission: K801719
- Applicant / Sponsor: Fred Sammons, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1250
- Decision date: 1980-08-04
Classification & Regulation
This clearance is catalogued under FDA product code HRW and 21 CFR 888.1250, within the Orthopedic review panel as a Class I device.