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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Decision Date To: 05/02/2024
 
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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WALLAC NEONATAL BIOTINIDASE TEST KIT, MO WALLAC, INC. DEN990008 K992284 02/15/2000
THE 3PM EGG MACHINE 3PM CO., INC. DEN990005 K984637 08/20/1999
KAVO DIAGNODENT KAVO AMERICA DEN990002 K983658 02/22/2000
DIAMOND PROBE/PERIO 2000 SYSTEM DIAMOND GENERAL DEVELOPMENT CORP. DEN980003 K980749 07/17/1998
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC CRANIAL TECHNOLOGIES, INC. DEN980001 K964992 05/29/1998
BraidE Embolization Assist Device Rapid Medical Ltd. DEN230064 02/21/2024
Body Temperature Software (BTS) Fitbit LLC DEN230050 12/15/2023
Sonu Sound Health Systems, Inc. DEN230045 12/04/2023
Sleep Apnea Feature Samsung Electronics Co., Ltd DEN230041 02/06/2024
Sepsis ImmunoScore Prenosis, Inc. DEN230036 04/02/2024
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