FDA 510(k), K222093, V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

510(K) Number: K222093
Device Name: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
Manufacturer: Anthony Piotrkowski
Device Classification Name: Sterilizer, Chemical
Regulation Number: MLR
Classification Product Code: KXA
Date Received: 07/15/2022
Decision Date: 09/09/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

251 Pages (143 of 395 original pages are fully redacted)