Clearance Summary
GLUCOSTABILIZER INSULIN DOSING CALCULATOR received FDA 510(k) clearance under submission number K141321, sponsored by Medical Decision Network. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2014-09-15.
- Submission: K141321
- Applicant / Sponsor: Medical Decision Network
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 2014-09-15
Classification & Regulation
This clearance is catalogued under FDA product code NDC and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.