Clearance Summary
PORTA-STAT received FDA 510(k) clearance under submission number K843340, sponsored by Porta-Stat, 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 1984-11-27.
- Submission: K843340
- Applicant / Sponsor: Porta-Stat, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1920
- Decision date: 1984-11-27
Classification & Regulation
This clearance is catalogued under FDA product code IWY and 21 CFR 892.1920, within the Radiology review panel as a Class I device.