Clearance Summary
BSI MODEL TIP received FDA 510(k) clearance under submission number K897191, sponsored by Bales Scientific, 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 1990-07-13.
- Submission: K897191
- Applicant / Sponsor: Bales Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 1990-07-13
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.