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510(k) K101264

TEMPUS IC PROFESSIONAL PATIENT MONITOR by Remote Diagnostic Technologies , Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2010
Date Received
May 5, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K133988 — TEMPUS PRO EXTENDED FEATURES (May 16, 2014)
  • K130773 — TEMPUS PRO PATIENT MONITOR (June 5, 2013)
  • K113105 — TEMPUSIC PATIENT MONITOR (December 15, 2011)
  • 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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