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FDA 510(k) Application Details - K223381
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K223381
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
Welch Allyn, Inc.
(a subsidiary of Baxter Healthcare Corporation)
4341 State Street Road
Skaneateles Falls, NY 13153 US
Other 510(k) Applications for this Company
Contact
Jeffrey E. Thompson
Other 510(k) Applications for this Contact
Regulation Number
886.1120
More FDA Info for this Regulation Number
Classification Product Code
HKI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/2022
Decision Date
03/15/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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