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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K946005
Device Name ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
Applicant
Astral, Ltd.
1114 Benfield Blvd.,
Suite K
Millersville,  MD  21108
Applicant Contact EARL D MARQUETTE JR.
Correspondent
Astral, Ltd.
1114 Benfield Blvd.,
Suite K
Millersville,  MD  21108
Correspondent Contact EARL D MARQUETTE JR.
Regulation Number880.5130
Classification Product Code
FMT  
Date Received12/09/1994
Decision Date 09/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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