Aveta System
FDA 510(k) clearance K191958 · decided 2019-10-01
Clearance details
- K-number
- K191958
- Device name
- Aveta System
- Applicant
- Meditrina, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-23
- Decision date
- 2019-10-01
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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.