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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name detector and alarm, arrhythmia
510(k) Number K090037
FOIA Releasable 510(k) K090037
Device Name MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
Applicant
MEDICALGORITHMICS SP Z.O.O.
245 WEST 107TH STREET
SUITE 11A
new york,  NY  10025
Applicant Contact martin jasinski
Correspondent
MEDICALGORITHMICS SP Z.O.O.
245 WEST 107TH STREET
SUITE 11A
new york,  NY  10025
Correspondent Contact martin jasinski
Regulation Number870.1025
Classification Product Code
DSI  
Date Received01/06/2009
Decision Date 05/22/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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