Clearance Summary
SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) received FDA 510(k) clearance under submission number K890513, sponsored by Micro Tronics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-04-28.
- Submission: K890513
- Applicant / Sponsor: Micro Tronics Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1989-04-28
Classification & Regulation
This clearance is catalogued under FDA product code OLZ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.