Capsule Technologie

FDA Regulatory Profile

Capsule Technologie has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 19, 2021

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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) clearances9Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K210204Capsule Vitals Plus Patient Monitoring SystemOct 19, 2021
K200856SmartLinx Vitals Plus Patient Monitoring SystemJul 10, 2020
K183638SmartLinx Vitals Plus Patient Monitoring SystemApr 17, 2019
K180734SmartLinx Vitals Plus Patient Monitoring SystemAug 8, 2018
K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx…Oct 24, 2017
K151071SmartLinx Vitals Plus Patient Monitoring SystemSep 17, 2015
K032142DATACAPTORAug 8, 2003
K020197MODIFICATION TO DATACAPTORFeb 21, 2002
K013019DATACAPTORDec 18, 2001