Clearance Summary
INFORMER PLUS received FDA 510(k) clearance under submission number K943481, sponsored by Micro-Tech Medical, Inc.. 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 1994-11-02.
- Submission: K943481
- Applicant / Sponsor: Micro-Tech Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 1994-11-02
Classification & Regulation
This clearance is catalogued under FDA product code KMI and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.