Clearance Summary
BIOPAK MEASUREMENT SYSTEM received FDA 510(k) clearance under submission number K981563, sponsored by Bio-Research Associates, Inc.. 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 1998-09-15.
- Submission: K981563
- Applicant / Sponsor: Bio-Research Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 1998-09-15
Classification & Regulation
This clearance is catalogued under FDA product code KZM and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.