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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 K991411
Device Name GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
Applicant
Gereonics, Inc.
4650-143 Dulin Rd.
Fallbrook,  CA  92028
Applicant Contact GERALD A ROST
Correspondent
Gereonics, Inc.
4650-143 Dulin Rd.
Fallbrook,  CA  92028
Correspondent Contact GERALD A ROST
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/26/1999
Decision Date 04/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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