FDA 510(k) Application Details - K242058

Device Classification Name

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510(K) Number K242058
Device Name Digital Prism Correction Feature (DPCF)
Applicant Apple Inc.
One Apple Park Way
Cupertino, CA 95014 US
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Contact Ian Marcus
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Regulation Number

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Classification Product Code SCW
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Date Received 07/15/2024
Decision Date 10/21/2024
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

FDA Source Information for K242058


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