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510(k) K051163

GALIX ECG PROFESSIONAL STATION by Galix Biomedical Instrumentation, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2006
Date Received
May 5, 2005
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 Galix Biomedical Instrumentation, Inc.

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

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