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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K062883
Device Name GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
Applicant
GEREONICS, INC.
244 LA BARRANCA DRIVE
SOLANA BEACH,  CA  92075
Applicant Contact GERALD ROST
Correspondent
GEREONICS, INC.
244 LA BARRANCA DRIVE
SOLANA BEACH,  CA  92075
Correspondent Contact GERALD ROST
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/26/2006
Decision Date 06/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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