G210 InviCell Plus with SignipHy pH monitoring
K-Number: K191020 · 2020-01-14
ApplicantCooperSurgical, Inc.
Decision Date2020-01-14
Product CodePUB
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
G210 InviCell Plus with SignipHy pH monitoring is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2020-01-14 under approval number K191020. The device is classified under product code PUB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the G210 InviCell Plus with SignipHy pH monitoring?
G210 InviCell Plus with SignipHy pH monitoring is a medical device that received FDA 510(k) clearance on 2020-01-14. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K191020.
When was G210 InviCell Plus with SignipHy pH monitoring approved by the FDA?
G210 InviCell Plus with SignipHy pH monitoring received FDA 510(k) clearance on 2020-01-14, under approval number K191020.
What company makes G210 InviCell Plus with SignipHy pH monitoring?
G210 InviCell Plus with SignipHy pH monitoring is manufactured by CooperSurgical, Inc..
What is the FDA product code for G210 InviCell Plus with SignipHy pH monitoring?
The FDA product code for G210 InviCell Plus with SignipHy pH monitoring is PUB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.