EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
FDA 510(k) clearance K223124 · decided 2022-11-18
Clearance details
- K-number
- K223124
- Device name
- EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
- Applicant
- DRTECH Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-10-03
- Decision date
- 2022-11-18
- Days to decision
- 46 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Jungwon-Gu, Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.