FDA 510(k), K222032, NEUROMARK System

FDA 510(k), K222032, NEUROMARK System

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510(K) Number: K222032
Device Name: NEUROMARK System
Manufacturer: Karen E. Peterson
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 07/11/2022
Decision Date: 10/26/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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