EQ-M
FDA 510(k) clearance K210475 · decided 2022-09-21
Clearance details
- K-number
- K210475
- Device name
- EQ-M
- Applicant
- Meta Systems Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-17
- Decision date
- 2022-09-21
- Days to decision
- 581 days
- Clearance type
- Traditional
- Product code
- EKX
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- 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.