Home / 510(k) Clearances / K130207

510(k) K130207

SPACELABS HEALTHCARE CARDIOEXPRESS by Spacelabs Healthcare, Ltd. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2013
Date Received
January 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Spacelabs Healthcare, Ltd.

  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • K211651 — Eclipse PRO (November 22, 2021)
  • 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)
  • 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 DPS

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)