AMSCO 600 Steam Sterilizer, V-PRO MaX 2 Low Temperature Sterilization System, V-PRO S2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle Of The AMSCO 7052HP And 7053HP Single Chamber Washer Disinfector

Washer, Cleaner, Automated, Endoscope

Steris

The following data is part of a premarket notification filed by Steris with the FDA for Amsco 600 Steam Sterilizer, V-pro Max 2 Low Temperature Sterilization System, V-pro S2 Low Temperature Sterilization System, Ras 12 Rack, Ras 12 Long Rack, Ras Cycle Of The Amsco 7052hp And 7053hp Single Chamber Washer Disinfector.

Pre-market Notification Details

Device IDK222543
510k NumberK222543
Device Name:AMSCO 600 Steam Sterilizer, V-PRO MaX 2 Low Temperature Sterilization System, V-PRO S2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle Of The AMSCO 7052HP And 7053HP Single Chamber Washer Disinfector
ClassificationWasher, Cleaner, Automated, Endoscope
Applicant Steris 5960 Heisley Rd Mentor,  OH  44060
ContactAnthony Piotrkowski
CorrespondentAnthony Piotrkowski
Steris 5960 Heisley Rd Mentor,  OH  44060
Product CodeNVE  
Subsequent Product CodeFLE
Subsequent Product CodeMLR
Subsequent Product CodePEC
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-22
Decision Date2022-08-25

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