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510(k) K092853

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM by Galix Biomedical Instrumentation, Inc. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2010
Date Received
September 16, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Galix Biomedical Instrumentation, Inc.

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  • K023080 — GALIX PACESTAR (June 11, 2003)
  • K992706 — GALIX GBI -3S-LP (March 15, 2001)
  • K971670 — 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER (January 29, 1998)

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