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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 K854626
Device Name COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B
Applicant
COMPUMED, INC.
8549 HIGUERA ST.
CULVER CITY,  CA  90230
Applicant Contact RICHARD A CARR
Correspondent
COMPUMED, INC.
8549 HIGUERA ST.
CULVER CITY,  CA  90230
Correspondent Contact RICHARD A CARR
Regulation Number868.1880
Classification Product Code
BZC  
Date Received11/18/1985
Decision Date 02/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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