Incontinence Probe
FDA 510(k) clearance K210441 · decided 2021-09-17
Clearance details
- K-number
- K210441
- Device name
- Incontinence Probe
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-12
- Decision date
- 2021-09-17
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- KPI
- Device class
- 2
- Regulation number
- 876.5320
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.