Truly Instrument Limited

FDA Regulatory Profile

Truly Instrument Limited has 0 FDA recalls, 0 inspections, 10 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Feb 17, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances10Oct 4, 2026Not statedCurrent
Inspections0Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K220276Infrared Thermometer TET-351Feb 17, 2023
K192023Arm Blood Pressure MonitorDec 23, 2019
K170545Automatic Wrist Bluetooth Blood Pressure MonitorNov 21, 2017
K161846Automatic Arm Bluetooth Blood Pressure MonitorOct 24, 2016
K113083TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORJan 19, 2012
K113085TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITORJan 12, 2012
K091415TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702MSep 4, 2009
K091434TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63MSep 4, 2009
K090564TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370Jun 24, 2009
K081852TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11Dec 12, 2008