FDA WARNING_LETTER - Insightra Medical Inc. - January 27, 2025

FDA WARNING_LETTER for Insightra Medical Inc. on January 27, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Insightra Medical Inc. on January 27, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.198

21 CFR 803.3

21 CFR 820.30(i)

21 CFR 803.50(a)(1)

21 CFR 820.100

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 820.198(a)

21 CFR 807.81(a)(3)(ii)

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Record Information

Company

Insightra Medical Inc.

Inspection Date

January 27, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Matthew G. Hillebrenner

ID: df6e32bc-b154-4c17-ada3-6e77ed4a2576

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