InBody
FDA 510(k) clearance K200442 · decided 2020-12-04
Clearance details
- K-number
- K200442
- Device name
- InBody
- Applicant
- Inbody Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-24
- Decision date
- 2020-12-04
- Days to decision
- 284 days
- Clearance type
- Abbreviated
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.