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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K173807
Device Name Accu O2 Oxygen Analyzer
Applicant
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Applicant Contact James Parker
Correspondent
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Correspondent Contact James Parker
Regulation Number868.1720
Classification Product Code
CCL  
Date Received12/15/2017
Decision Date 05/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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