BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER

K072008 · Braemar, Inc. · DRG · Oct 3, 2007 · Cardiovascular

Device Facts

Record IDK072008
Device NameBRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
ApplicantBraemar, Inc.
Product CodeDRG · Cardiovascular
Decision DateOct 3, 2007
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2910
Device ClassClass 2

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Innolitics

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