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510(k) K023080

GALIX PACESTAR by Galix Biomedical Instrumentation, Inc. — Product Code DTE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2003
Date Received
September 17, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
Review Panel
CV
Submission Type

Other clearances by Galix Biomedical Instrumentation, Inc.

  • K092853 — 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM (July 9, 2010)
  • K051163 — GALIX ECG PROFESSIONAL STATION (January 31, 2006)
  • K030145 — GALIX WINTER (September 17, 2003)
  • K992706 — GALIX GBI -3S-LP (March 15, 2001)
  • K971670 — 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER (January 29, 1998)

Other clearances for product code DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)