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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 Interpretor (Diagnostic)
510(k) Number K863953
Device Name SPIROMETRICS MODEL 2500 FLOWMATE(TM)
Applicant
Spirometrics, Inc.
Suite 1203 Crystal Plz. Bldg1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Applicant Contact JERRY BERKSTRESSER
Correspondent
Spirometrics, Inc.
Suite 1203 Crystal Plz. Bldg1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Correspondent Contact JERRY BERKSTRESSER
Regulation Number868.1900
Classification Product Code
BZM  
Date Received10/10/1986
Decision Date 01/15/1987
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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