Clearance Summary
CAL-COUNT received FDA 510(k) clearance under submission number K801868, sponsored by Bayshore Systems Corp.. 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 1980-08-27.
- Submission: K801868
- Applicant / Sponsor: Bayshore Systems Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 1980-08-27
Classification & Regulation
This clearance is catalogued under FDA product code ISD and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.