FDA WARNING_LETTER - Durazo Medical Biomagnetism - June 12, 2020

FDA WARNING_LETTER for Durazo Medical Biomagnetism on June 12, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Durazo Medical Biomagnetism on June 12, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

21 U.S.C. 331(k)

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 U.S.C. 352(o)

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Record Information

Company

Durazo Medical Biomagnetism

Inspection Date

June 12, 2020

Product Type

Devices

Office

Office of Health Technology 5 (Neurological and Physical Medicine Devices)

People

ID: cccf726a-40de-4ae8-8391-f73d196d6f39

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