G210 InviCell Plus With SignipHy PH Monitoring

Accessory, Assisted Reproduction, Exempt

CooperSurgical Inc.

The following data is part of a premarket notification filed by Coopersurgical Inc. with the FDA for G210 Invicell Plus With Signiphy Ph Monitoring.

Pre-market Notification Details

Device IDK191020
510k NumberK191020
Device Name:G210 InviCell Plus With SignipHy PH Monitoring
ClassificationAccessory, Assisted Reproduction, Exempt
Applicant CooperSurgical Inc. 95 Corporate Drive Trumbull,  CT  06611
ContactKyle Hooper
CorrespondentKyle Hooper
CooperSurgical Inc. 95 Corporate Drive Trumbull,  CT  06611
Product CodePUB  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-17
Decision Date2020-01-14

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