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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K992214
Device Name OXYCON PRO
Applicant
Erich Jaeger B.V.
Regulierening 11
Nl-3981 La Bunnik,  NL NL-3981
Applicant Contact LEO DEN BAKKER
Correspondent
Erich Jaeger B.V.
Regulierening 11
Nl-3981 La Bunnik,  NL NL-3981
Correspondent Contact LEO DEN BAKKER
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Codes
DPS   MLC   MWI  
Date Received07/01/1999
Decision Date 02/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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