EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
FDA 510(k) clearance K192400 · decided 2019-10-03
Clearance details
- K-number
- K192400
- Device name
- EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
- Applicant
- DRTECH Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-09-03
- Decision date
- 2019-10-03
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Jungwon-Gu, Seongam-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.