FDA WARNING_LETTER - Cardiac Science Corporation - October 01, 2009

FDA WARNING_LETTER for Cardiac Science Corporation on October 01, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Cardiac Science Corporation on October 01, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.10(b)(1)

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

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(a)(4)

21 CFR 820.30(c)

21 CFR 820.30(f)

21 U.S.C. 351(h)

21 CFR 820.100(a)(3)

21 U.S.C. 360i

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Record Information

Company

Cardiac Science Corporation

Inspection Date

October 1, 2009

Product Type

Devices

Office

Seattle District Office

People

ID: a2b08dce-948a-4764-93ec-f2e8a4f94f37

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