FDA WARNING_LETTER - Apnea Sciences Inc - December 06, 2012

FDA WARNING_LETTER for Apnea Sciences Inc on December 06, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Apnea Sciences Inc on December 06, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.80(d)

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

21 CFR 820.30(h)

21 CFR 820.30(a)

21 U.S.C. 360c(i)(1)(A)

21 U.S.C. 352(a)

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

21 CFR 820.100(a)

21 CFR 801.109

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Record Information

Company

Apnea Sciences Inc

Inspection Date

December 6, 2012

Product Type

Devices

Office

Los Angeles District Office

People

ID: 643cecd2-98a3-46d3-b5b7-be2525c78fd4

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