FDA WARNING_LETTER - Heartsine Technologies, LTD - November 29, 2007

FDA WARNING_LETTER for Heartsine Technologies, LTD on November 29, 2007. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Heartsine Technologies, LTD on November 29, 2007. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.120

21 CFR 820.250(h)

21 CFR 801.109(h)

21 CFR 820.25(h)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.80(b)

21 U.S.C. 381(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

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Record Information

Company

Heartsine Technologies, LTD

Inspection Date

November 29, 2007

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 045214fd-b03e-43b9-9a3b-950b3eef96c7

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