Clearance Summary
IR VIEWER received FDA 510(k) clearance under submission number K042679, sponsored by Infrared Imaging Systems, 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 2004-12-10.
- Submission: K042679
- Applicant / Sponsor: Infrared Imaging Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6970
- Decision date: 2004-12-10
Classification & Regulation
This clearance is catalogued under FDA product code KZA and 21 CFR 880.6970, within the General Hospital review panel as a Class I device.