Zeroveno
FDA 510(k) clearance K192337 · decided 2020-06-22
Clearance details
- K-number
- K192337
- Device name
- Zeroveno
- Applicant
- Dimedi Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-28
- Decision date
- 2020-06-22
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wonju-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.