Clearance Summary
ABDOMINAL FETAL ECG MODULE received FDA 510(k) clearance under submission number K770245, sponsored by Mennen Greatbatch Electonics. 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 1977-02-14.
- Submission: K770245
- Applicant / Sponsor: Mennen Greatbatch Electonics
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2600
- Decision date: 1977-02-14
Classification & Regulation
This clearance is catalogued under FDA product code KXN and 21 CFR 884.2600, within the Obstetrics/Gynecology review panel as a Class II device.