ClearanceBrief
Company ยท US

Galix Biomedical Instrumentation, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2010. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2
DPSElectrocardiograph1
DQKComputer, Diagnostic, Programmable1
DSHRecorder, Magnetic Tape, Medical1
DTEPulse-Generator, Pacemaker, External1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 9, 2010K0928533 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
Galix Biomedical Instrumentation, Inc.
MLO
Jan 31, 2006K051163GALIX ECG PROFESSIONAL STATION
Galix Biomedical Instrumentation, Inc.
DPS
Sep 17, 2003K030145GALIX WINTER
Galix Biomedical Instrumentation, Inc.
DQK
Jun 11, 2003K023080GALIX PACESTAR
Galix Biomedical Instrumentation, Inc.
DTE
Mar 15, 2001K992706GALIX GBI -3S-LP
Galix Biomedical Instrumentation, Inc.
MLO
Jan 29, 1998K9716703 CHANNEL DIGITAL AMBULATORY ECG RECORDER
Galix Biomedical Instrumentation, Inc.
DSH

Latest recalls

DateFirm and productCodeLinked 510(k)
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