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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K040910
Device Name INFANT INCUBATOR, MODEL CHS-I1000
Applicant
Choong Wae Medical Corp.
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact RONALD D ARKIN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact CHAN YO WON
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received04/08/2004
Decision Date 04/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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