Clearance Summary
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K062388, sponsored by Docusys. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2007-02-22.
- Submission: K062388
- Applicant / Sponsor: Docusys
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2007-02-22
Classification & Regulation
This clearance is catalogued under FDA product code BSZ and 21 CFR 868.5160, within the Anesthesiology review panel as a Class II device.