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FDA 510(k)

Nerivio, FGD000075-4.7

K-Number: K203181 · 2021-01-22

ApplicantTheranica Bioelectronics , Ltd.
Decision Date2021-01-22
Product CodeQGT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nerivio, FGD000075-4.7 is the device name listed in this FDA 510(k) record. The listed applicant is Theranica Bioelectronics , Ltd.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K203181. The device is classified under product code QGT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nerivio, FGD000075-4.7?

Nerivio, FGD000075-4.7 is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Theranica Bioelectronics , Ltd.. The 510(k) number is K203181.

When did Nerivio, FGD000075-4.7 receive FDA 510(k) clearance?

Nerivio, FGD000075-4.7 received FDA 510(k) clearance on 2021-01-22, under 510(k) number K203181.

Who is the listed applicant for Nerivio, FGD000075-4.7?

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

What is the FDA product code for Nerivio, FGD000075-4.7?

The FDA product code for Nerivio, FGD000075-4.7 is QGT.

Other records listing Theranica Bioelectronics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232152NerivioInfinityK223169Nerivio

Related Devices (Code: QGT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250405Nerivio; Nerivio InfinityTheranica Bio-Electronics, Ltd.K241756Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd.K232152NerivioInfinityTheranica Bioelectronics , Ltd.K223169NerivioTheranica Bioelectronics , Ltd.K201824NerivioTheranica Bio-Electronics, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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