Clearance Summary
MICRONJET 600 received FDA 510(k) clearance under submission number K092746, sponsored by Nanopass Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-02-03.
- Submission: K092746
- Applicant / Sponsor: Nanopass Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2010-02-03
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.