Esteya
FDA 510(k) clearance K213942 · decided 2022-01-11
Clearance details
- K-number
- K213942
- Device name
- Esteya
- Applicant
- Nucletron B.V.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-17
- Decision date
- 2022-01-11
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Veenendaal, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.