Clearance Summary
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM received FDA 510(k) clearance under submission number K083413, sponsored by Philips Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2008-12-18.
- Submission: K083413
- Applicant / Sponsor: Philips Medical Systems
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2008-12-18
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.