IR VIEWER— 510(k) K042679
Substantially EquivalentInfrared Imaging Systems, Inc.
FDA 510(k) clearance K042679 for IR VIEWER, Substantially Equivalent on 2004-12-10. Applicant: Infrared Imaging Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Infrared Imaging Systems, Inc.
- Product code
- Code KZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbus, OH, US
Recent devices under product code KZA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.