FDA 510(k) Application Details - K221892

Device Classification Name Rhinoanemometer (Measurement Of Nasal Decongestion)

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510(K) Number K221892
Device Name Rhinoanemometer (Measurement Of Nasal Decongestion)
Applicant PacificMD Biotech Llc
3195 Saint Rose Pkwy, Suite 210
Henderson, NV 89052 US
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Contact Jetmir Palushi
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Regulation Number 868.1800

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Classification Product Code BXQ
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Date Received 06/29/2022
Decision Date 10/05/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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