FDA 510(k) Application Details - DEN230067

Device Classification Name

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510(K) Number DEN230067
Device Name Chronos«
Applicant Germitec
19 rue Vauban
Bordeaux 33000 FR
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Contact Vincent Gardes
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Regulation Number

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Classification Product Code SCS
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Date Received 09/28/2023
Decision Date 08/28/2024
Decision DENG -
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review

FDA Source Information for DEN230067


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