HealthMammo— 510(k) K200905
Substantially EquivalentZebra Medical Vision, Ltd.
FDA 510(k) clearance K200905 for HealthMammo, Substantially Equivalent on 2020-07-16. Applicant: Zebra Medical Vision, Ltd.. Device class: 2.
Clearance details
- Applicant
- Zebra Medical Vision, Ltd.
- Product code
- Code QFM
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sefayim, IL
Recent devices under product code QFM
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