Visby Medical Sexual Health
FDA 510(k) clearance K200748 · decided 2021-08-26
Clearance details
- K-number
- K200748
- Device name
- Visby Medical Sexual Health
- Applicant
- Visby Medical
- Decision
- Substantially Equivalent
- Date received
- 2020-03-23
- Decision date
- 2021-08-26
- Days to decision
- 521 days
- Clearance type
- Dual Track
- Product code
- QEP
- Device class
- 2
- Regulation number
- 866.3393
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.