Clearance Summary
TABLE, EXAMINATION received FDA 510(k) clearance under submission number K770437, sponsored by I E Industries. 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 1977-03-23.
- Submission: K770437
- Applicant / Sponsor: I E Industries
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1977-03-23
Classification & Regulation
This clearance is catalogued under FDA product code KNC and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.