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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 K945359
Device Name AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H
Applicant
Artema Medical AB
Rissneleden 136
S-172 48 Sundyberg
Sweden,  SE
Applicant Contact CARL HAMILTON
Correspondent
Artema Medical AB
Rissneleden 136
S-172 48 Sundyberg
Sweden,  SE
Correspondent Contact CARL HAMILTON
Regulation Number868.5375
Classification Product Code
BYD  
Date Received11/02/1994
Decision Date 02/21/1995
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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