Clearance Summary
CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 received FDA 510(k) clearance under submission number K921727, sponsored by Viggo-Spectramed. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1994-05-10.
- Submission: K921727
- Applicant / Sponsor: Viggo-Spectramed
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1994-05-10
Classification & Regulation
This clearance is catalogued under FDA product code KNF and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.