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FDA 510(k) Application Details - K210137
Device Classification Name
Esophagoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K210137
Device Name
Esophagoscope (Flexible Or Rigid)
Applicant
Lucid Diagnostics, Inc.
One Grand Central Place, Suite 4600
New York, NY 10165 US
Other 510(k) Applications for this Company
Contact
Lishan Aklog
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
01/19/2021
Decision Date
02/18/2021
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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