Comfort Marker 2.0.
FDA 510(k) clearance DEN200041 · decided 2021-12-10
Clearance details
- K-number
- DEN200041
- Device name
- Comfort Marker 2.0.
- Applicant
- Medical Precision BV
- Decision
- Unknown
- Date received
- 2020-06-22
- Decision date
- 2021-12-10
- Days to decision
- 536 days
- Clearance type
- Direct
- Product code
- QRN
- Device class
- 2
- Regulation number
- 892.5785
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Zwolle, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Comfort Marker 2.0 (K222112) | Medical Precision BV | 2023-03-30 |
Recalls involving this device
No recalls on record reference this clearance.