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FDA 510(k) Application Details - K232015
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K232015
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
Lenzkirch 79853 DE
Other 510(k) Applications for this Company
Contact
Reinhold Storch
Other 510(k) Applications for this Contact
Regulation Number
874.4760
More FDA Info for this Regulation Number
Classification Product Code
EOB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/06/2023
Decision Date
08/03/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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