G210 InviCell Plus with SignipHy pH monitoring— 510(k) K191020
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K191020 for G210 InviCell Plus with SignipHy pH monitoring, Substantially Equivalent on 2020-01-14. Applicant: CooperSurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperSurgical, Inc.
- Product code
- Code PUB
- Device class
- Class 2
- Regulation
- 21 CFR 884.6120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trumbull, CT, US
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