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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mass Spectrometer, Clinical Use
510(k) Number K854076
Device Name MGA 2000 GAS ANALYSER
Applicant
Airspec , Ltd.
Airport Industrial Estate
Biggin Hill Westerham Kent #16
Tn 16 3bw, England,  GB
Applicant Contact CRAWFORD
Correspondent
Airspec , Ltd.
Airport Industrial Estate
Biggin Hill Westerham Kent #16
Tn 16 3bw, England,  GB
Correspondent Contact CRAWFORD
Regulation Number862.2860
Classification Product Code
DOP  
Date Received10/07/1985
Decision Date 12/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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