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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 K964939
Device Name THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
Applicant
CREATIVE BIOMEDICS, INC.
934-B CALLE NEGOCIO
SAN CLEMENTE,  CA  92673
Applicant Contact DANIEL BROWN
Correspondent
CREATIVE BIOMEDICS, INC.
934-B CALLE NEGOCIO
SAN CLEMENTE,  CA  92673
Correspondent Contact DANIEL BROWN
Regulation Number868.1880
Classification Product Code
BZC  
Date Received12/10/1996
Decision Date 03/06/1997
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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