Clearance Summary
CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM received FDA 510(k) clearance under submission number K895775, sponsored by Medtronic Vascular. 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 1990-04-23.
- Submission: K895775
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5525
- Decision date: 1990-04-23
Classification & Regulation
This clearance is catalogued under FDA product code KTB and 21 CFR 890.5525, within the Physical Medicine review panel as a Class II device.