Clearance Summary
MODEL DT-BAL, BALANCE SAVER received FDA 510(k) clearance under submission number K895323, sponsored by Spectramed, Inc.. 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 1989-10-24.
- Submission: K895323
- Applicant / Sponsor: Spectramed, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2700
- Decision date: 1989-10-24
Classification & Regulation
This clearance is catalogued under FDA product code KXO and 21 CFR 884.2700, within the Obstetrics/Gynecology review panel as a Class II device.