FDA WARNING_LETTER - Spacelabs Healthcare Inc - April 02, 2014

FDA WARNING_LETTER for Spacelabs Healthcare Inc on April 02, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Spacelabs Healthcare Inc on April 02, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 820.100(a)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.80(b)

21 CFR 820.90(a)

21 CFR 820.198(a)

21 CFR 803

21 CFR 820.30(f)

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Record Information

Company

Spacelabs Healthcare Inc

Inspection Date

April 2, 2014

Product Type

Devices

Office

Seattle District Office

People

ID: ea469af3-62b0-4e71-9927-8ffef17d2531

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