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510(k) K211651

Eclipse PRO by Spacelabs Healthcare, Ltd. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2021
Date Received
May 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Spacelabs Healthcare, Ltd.

  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • K201921 — Spacelabs Lifescreen PRO Analyzer (March 26, 2021)
  • K152881 — SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM (April 1, 2016)
  • K150329 — elance Vital Signs Monitor, Central Monitor Software (November 5, 2015)
  • K141113 — SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE (September 26, 2014)
  • K141156 — SPACELABS HEALTHCARE TELEMETRY RECEIVER (September 9, 2014)
  • K130207 — SPACELABS HEALTHCARE CARDIOEXPRESS (July 23, 2013)
  • K122146 — XHIBIT CENTRAL STATION, MODEL 96102 (April 22, 2013)
  • K130112 — CAPNO MODULE, 92517 (March 21, 2013)
  • K121017 — CAPNOGRAPHY PAD (92516) (July 13, 2012)

Other clearances for product code MWJ

  • K231424 — HeartBeam AIMIGo(TM) System (December 13, 2024)
  • K233864 — ASSURE Wearable ECG (May 7, 2024)
  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • K222017 — Biotres (July 28, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K211709 — Biotres (January 19, 2022)
  • K173156 — Integrated CardioRespiratory System (June 8, 2018)
  • K161062 — NR Recorder (June 13, 2016)
  • K152626 — H3+ Holter Recorder (February 26, 2016)
  • K142424 — DR300 HOLTER MONITOR (November 25, 2014)