Home / 510(k) Clearances / K010436

510(k) K010436

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 by Remote Diagnostic Technologies , Ltd. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2001
Date Received
February 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
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)
  • K133988 — TEMPUS PRO EXTENDED FEATURES (May 16, 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)

Other clearances for product code DXH

  • K250233 — PreemptiveAI Clinical SDK (February 13, 2026)
  • K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System (December 8, 2025)
  • K243438 — MEMO Patch M (MPT-E08R-UNC01) (December 5, 2025)
  • K243981 — Hexoskin Medical System (7100-00016) (November 18, 2025)
  • K243003 — VitalSigns 1-Lead Holter (VSH101) (June 17, 2025)
  • K233521 — QT ECG (QTERD100) (December 6, 2023)
  • K222842 — V-Patch Cardiac Monitor (October 20, 2022)
  • K220795 — QT ECG (September 26, 2022)
  • K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls (July 19, 2022)
  • K220350 — KardiaMobile 6L (May 25, 2022)