FDA 510(k)

G210 InviCell Plus with SignipHy pH monitoring

Numéro K : K191020 · 2020-01-14

Date de décision2020-01-14

Code produitPUB

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

G210 InviCell Plus with SignipHy pH monitoring is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K191020. The device is classified under product code PUB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K191020.

When did G210 InviCell Plus with SignipHy pH monitoring receive FDA 510(k) clearance?

G210 InviCell Plus with SignipHy pH monitoring received FDA 510(k) clearance on 2020-01-14, under 510(k) number K191020.

Who is the listed applicant for G210 InviCell Plus with SignipHy pH monitoring?

The FDA 510(k) record lists CooperSurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Source officielle

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