Comfort Marker 2.0— 510(k) K222112
Substantially EquivalentMedical Precision BV
FDA 510(k) clearance K222112 for Comfort Marker 2.0, Substantially Equivalent on 2023-03-30. Applicant: Medical Precision BV. Device class: 2.
Clearance details
- Applicant
- Medical Precision BV
- Product code
- Code QRN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5785
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zwolle, NL
Recent devices under product code QRN
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