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FDA 510(k)

gammaCore Sapphire

K-Number: K191830 · 2020-03-26

ApplicantElectrocore, Inc.
Decision Date2020-03-26
Product CodePKR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

gammaCore Sapphire is the device name listed in this FDA 510(k) record. The listed applicant is Electrocore, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K191830. The device is classified under product code PKR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gammaCore Sapphire?

gammaCore Sapphire is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Electrocore, Inc.. The 510(k) number is K191830.

When did gammaCore Sapphire receive FDA 510(k) clearance?

gammaCore Sapphire received FDA 510(k) clearance on 2020-03-26, under 510(k) number K191830.

Who is the listed applicant for gammaCore Sapphire?

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

What is the FDA product code for gammaCore Sapphire?

The FDA product code for gammaCore Sapphire is PKR.

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Other records listing Electrocore, Inc. 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.

K211856gammaCore SapphireK203546gammaCore SapphireK182369gammaCore SapphireK180538gammaCore SapphireK173442gammaCore-SK171306gammaCore-S

View all 7 devices →

Related Devices (Code: PKR)

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.

K211856gammaCore SapphireElectrocore, Inc.K203546gammaCore SapphireElectrocore, Inc.K182369gammaCore SapphireElectrocore, Inc.K180538gammaCore SapphireElectrocore, LLCK173442gammaCore-SElectrocore, LLCK172270gammaCore-2Eletrocore, LLC

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.

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