Subpart C—Monitoring Devices

FDA submissions for Subpart C—Monitoring Devices in the Gastroenterology, Urology (GU) review panel, including product codes and regulations.

Section range: §§ 876.2040–876.2100

CFR Part: 876

Product Codes

Product CodeDevice NameRegulationClassDevices
KPNAlarm, Conditioned Response Enuresis876.2040237
OQTProstate Lesion, Documentation, System876.205021
QEFPressure Ulcer Management Tool876.210011
Innolitics

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