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510(k) K173768

Tempus Pro Patient Monitor by Remote Diagnostic Technologies , Ltd. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2018
Date Received
December 11, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Remote Diagnostic Technologies , Ltd.

  • 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)
  • K010436 — TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01- (May 14, 2001)

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