Clearance Summary
HOSPITAL'S-SPEC received FDA 510(k) clearance under submission number K842014, sponsored by Merex Co.. 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 1984-08-17.
- Submission: K842014
- Applicant / Sponsor: Merex Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1984-08-17
Classification & Regulation
This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.