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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 K063096
Device Name PRECISION OXYGEN MONITOR
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 Received10/10/2006
Decision Date 02/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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