FDA 510(k) Application Details - K241140

Device Classification Name Purifier, Air, Ultraviolet, Medical

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510(K) Number K241140
Device Name Purifier, Air, Ultraviolet, Medical
Applicant Applied Photonix, LLC
3802 Spectrum Blvd.
Suite 202-1
Tampa, FL 33612 US
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Contact D. Yogi Goswami
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Regulation Number 880.6500

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Classification Product Code FRA
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Date Received 04/24/2024
Decision Date 08/01/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241140


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