Clearance Summary
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. received FDA 510(k) clearance under submission number K901084, sponsored by Healthdyne Cardiovascular, 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 1990-06-01.
- Submission: K901084
- Applicant / Sponsor: Healthdyne Cardiovascular, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2700
- Decision date: 1990-06-01
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.