Clearance Summary
CRY-ACTRACKERCAM received FDA 510(k) clearance under submission number K110305, sponsored by Brymill Cryogenic Cystems. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-01-13.
- Submission: K110305
- Applicant / Sponsor: Brymill Cryogenic Cystems
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2900
- Decision date: 2012-01-13
Classification & Regulation
This clearance is catalogued under FDA product code FQZ and 21 CFR 880.2900, within the General Hospital review panel as a Class I device.