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510(k) K191020

Device
G210 InviCell Plus With SignipHy PH Monitoring
Applicant
CooperSurgical Inc.
510(k) number
K191020
Product code
PUB  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-14
Date received
2019-04-17
Regulation
884.6120
Classification name
Accessory, Assisted Reproduction, Exempt
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kyle Hooper
Address
95 Corporate Dr. Trumbull CT US 06611 06611

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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