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FDA 510(k) Application Details - K230339
Device Classification Name
Esophagoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K230339
Device Name
Esophagoscope (Flexible Or Rigid)
Applicant
Lucid Diagnostics, Inc.
360 Madison Ave, Floor 25
New York, NY 10017 US
Other 510(k) Applications for this Company
Contact
Deepika Lakhani
Other 510(k) Applications for this Contact
Regulation Number
874.4710
More FDA Info for this Regulation Number
Classification Product Code
EOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/07/2023
Decision Date
02/24/2023
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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