Clearance Summary
BOBCAT DX received FDA 510(k) clearance under submission number K970543, sponsored by Quest Enabling Designs , Ltd.. 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 1997-06-26.
- Submission: K970543
- Applicant / Sponsor: Quest Enabling Designs , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3900
- Decision date: 1997-06-26
Classification & Regulation
This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.