Home / 510(k) Clearances / K130056

510(k) K130056

PATIENT MONITOR by Ld Technology, LLC — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2013
Date Received
January 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Ld Technology, LLC

  • K200287 — BP-BT Kiosk (May 15, 2020)
  • K200141 — Oxi-W System (April 27, 2020)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K160956 — LD-Oxi system (July 6, 2016)
  • K152216 — SudoC (September 24, 2015)
  • K143152 — TM-ABI system (July 22, 2015)
  • K140412 — ANS1 SOFTWARE (May 22, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K113264 — ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) (March 2, 2012)
  • K103026 — ELECTRO SENSOR -BODY COMPOSITION (March 29, 2011)

Other clearances for product code MWI

  • K250135 — WAVE Clinical Platform (2.0.000) (January 16, 2026)
  • K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (August 27, 2025)
  • K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (June 6, 2025)
  • K241958 — WARD-CSS (v1.2.x) (February 14, 2025)
  • K243146 — iCare APP (February 3, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (December 10, 2024)
  • K233446 — AMC Health CareConsole (September 27, 2024)
  • K240236 — Happy Ring Health Monitoring System (September 24, 2024)
  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)