Clearance Summary
MICRONAIRE ISO-HOOD MAX 5UV received FDA 510(k) clearance under submission number K912142, sponsored by Micronaire Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-10-30.
- Submission: K912142
- Applicant / Sponsor: Micronaire Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1991-10-30
Classification & Regulation
This clearance is catalogued under FDA product code EAZ and 21 CFR 872.4630, within the Dental review panel as a Class I device.