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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K843996
Device Name TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER
Applicant
Equilibrated Bio Systems, Inc.
900 Walt Whitman Rd.
Melville,  NY  11747
Applicant Contact ALEX STENZLER
Correspondent
Equilibrated Bio Systems, Inc.
900 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact ALEX STENZLER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/11/1984
Decision Date 11/20/1984
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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