FDA.reportPublic FDA data

510(k) K203199

Device
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
Applicant
STERIS Corporation
510(k) number
K203199
Product code
NVE
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-01
Date received
2020-10-29
Regulation
876.1500
Classification name
Washer, Cleaner, Automated, Endoscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Nalepka
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NVE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorSteris2022-09-30
K222543AMSCO 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 DisinfectorSteris2022-08-25
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