FDA WARNING_LETTER - ZYTO Technologies, Inc. - December 13, 2022

FDA WARNING_LETTER for ZYTO Technologies, Inc. on December 13, 2022. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for ZYTO Technologies, Inc. on December 13, 2022. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.100(a)(4)

21 CFR 820.100(a)(3)

21 CFR 820.184

21 CFR 820.198

21 U.S.C. 352(o)

FD&C Act 201(h)

21 U.S.C. 321(h)

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

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Record Information

Company

ZYTO Technologies, Inc.

Inspection Date

December 13, 2022

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: 9db93290-c955-4d1e-ad1b-3692a0080fb7

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