FDA WARNING_LETTER - NeuroField, Inc. - October 06, 2021

FDA WARNING_LETTER for NeuroField, Inc. on October 06, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for NeuroField, Inc. on October 06, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 U.S.C. 360j(g)

21 CFR 882.5050

21 CFR 882.9

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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Record Information

Company

NeuroField, Inc.

Inspection Date

October 6, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: a38138d1-ad3f-4e91-a767-44b659e4b341

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