CAMTEX 1000— 510(k) K840134
Substantially EquivalentDigital Imaging Co. of America
FDA 510(k) clearance K840134 for CAMTEX 1000, Substantially Equivalent on 1984-03-16. Applicant: Digital Imaging Co. of America. Device class: 2.
Clearance details
- Applicant
- Digital Imaging Co. of America
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code JAA
view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.