Clearance Summary
POST EXTRA SYSTOLIC POSTENTLATOR received FDA 510(k) clearance under submission number K791959, sponsored by Medrad, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1980-01-09.
- Submission: K791959
- Applicant / Sponsor: Medrad, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1970
- Decision date: 1980-01-09
Classification & Regulation
This clearance is catalogued under FDA product code IXO and 21 CFR 892.1970, within the Radiology review panel as a Class I device.