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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K103563
Device Name PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
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 Number868.5440
Classification Product Code
CAW  
Date Received12/06/2010
Decision Date 07/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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