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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K933597
Device Name AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH
Applicant
Arthro-Medic, Inc.
Rissneleden 136
S-172 48 Sundbybert
Sweden,  SE
Applicant Contact CAROL HAMILTON
Correspondent
Arthro-Medic, Inc.
Rissneleden 136
S-172 48 Sundbybert
Sweden,  SE
Correspondent Contact CAROL HAMILTON
Regulation Number868.5375
Classification Product Code
BYD  
Subsequent Product Code
CAH  
Date Received07/26/1993
Decision Date 11/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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