CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris— 510(k) K171353
Substantially EquivalentMinxray, Inc.
FDA 510(k) clearance K171353 for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris, Substantially Equivalent on 2017-06-07. Applicant: Minxray, Inc.. Device class: 2.
Clearance details
- Applicant
- Minxray, Inc.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Northbrook, IL, US
Recent devices under product code IZL
view allMore clearances from Minxray, Inc.
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.