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510(k) K971670

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER by Galix Biomedical Instrumentation, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1998
Date Received
May 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
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)
  • K023080 — GALIX PACESTAR (June 11, 2003)
  • K992706 — GALIX GBI -3S-LP (March 15, 2001)

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