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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumotachometer
510(k) Number K853085
Device Name PAX METER
Applicant
Peace Medical, Inc.
9 Great Meadow Ln.
East Hanover,  NJ  07936
Applicant Contact KEVIN FEGAN
Correspondent
Peace Medical, Inc.
9 Great Meadow Ln.
East Hanover,  NJ  07936
Correspondent Contact KEVIN FEGAN
Regulation Number868.2550
Classification Product Code
JAX  
Date Received07/23/1985
Decision Date 09/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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