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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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81 to 90 of 415 results
Decision Date To: 05/23/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
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ClearUP Sinus Relief Tivic Health Systems Inc. DEN200006 03/05/2021
cNEP Airway Sommetrics DEN140024 12/23/2015
cobas EBV, cobas EBV/BKV Control Kit, co Roche Molecular Systems, Inc. DEN200015 07/30/2020
cobas vivoDx MRSA Roche Molecular Systems, Inc. DEN190016 12/05/2019
COGNIVUE CEREBRAL ASSESSMENT SYSTEMS, INC DEN130033 06/05/2015
Cognoa ASD Diagnosis Aid Cognoa, Inc. DEN200069 06/02/2021
Comaneci, Comaneci Petit, Comaneci 17 Rapid-Medical Ltd. DEN170064 04/24/2019
Comfort Marker 2.0. Medical Precision B.V. DEN200041 12/10/2021
Companion LGCH, INC DEN140033 02/16/2017
COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. DEN060006 K060028 01/30/2007
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