Clearance Summary
QA PRESSURE MEASUREMENT SYSTEM received FDA 510(k) clearance under submission number K925052, sponsored by Gabel Medical Instruments, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1993-03-09.
- Submission: K925052
- Applicant / Sponsor: Gabel Medical Instruments, Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.1600
- Decision date: 1993-03-09
Classification & Regulation
This clearance is catalogued under FDA product code JFC and 21 CFR 890.1600, within the Physical Medicine review panel as a Class I device.