Home / 510(k) Clearances / K133988

510(k) K133988

TEMPUS PRO EXTENDED FEATURES by Remote Diagnostic Technologies , Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2014
Date Received
December 26, 2013
Clearance Type
Abbreviated
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 Remote Diagnostic Technologies , Ltd.

  • K173768 — Tempus Pro Patient Monitor (January 10, 2018)
  • K170567 — Tempus Pro Patient Monitor (July 6, 2017)
  • K133973 — TEMPUS PRO WITH ENHANCED FEATURES (August 14, 2014)
  • K134014 — TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) (August 12, 2014)
  • K130773 — TEMPUS PRO PATIENT MONITOR (June 5, 2013)
  • K113105 — TEMPUSIC PATIENT MONITOR (December 15, 2011)
  • K101264 — TEMPUS IC PROFESSIONAL PATIENT MONITOR (May 11, 2010)
  • K082718 — TEMPUSIC PATIENT MONITOR (October 10, 2008)
  • K033410 — TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 (March 5, 2004)
  • K010436 — TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01- (May 14, 2001)

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)