EEVA SYSTEM— 510(k) K142147
Substantially EquivalentAuxogyn, Inc.
FDA 510(k) clearance K142147 for EEVA SYSTEM, Substantially Equivalent on 2014-11-24. Applicant: Auxogyn, Inc.. Device class: 2.
Clearance details
- Applicant
- Auxogyn, Inc.
- Product code
- Code PBH
- Device class
- Class 2
- Regulation
- 21 CFR 884.6195
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
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