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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K014102
Device Name PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
Applicant
ATOS MEDICAL AB
KRAFTGATAN 8
HORBY,  SE SE-242 22
Applicant Contact EDDY ABERG
Correspondent
ATOS MEDICAL AB
KRAFTGATAN 8
HORBY,  SE SE-242 22
Correspondent Contact EDDY ABERG
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/13/2001
Decision Date 02/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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