RAS 12 Rack, RAS 12 Long Rack; RAS Cycle Of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

Washer, Cleaner, Automated, Endoscope

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Ras 12 Rack, Ras 12 Long Rack; Ras Cycle Of Amsco 7052hp/7053hp Single Chamber Washer/disinfector.

Pre-market Notification Details

• Device ID: K190081
• 510k Number: K190081
• Device Name: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle Of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
• Classification: Washer, Cleaner, Automated, Endoscope
• Applicant: STERIS Corporation 5960 Heisley Rd Mentor, OH 44060
• Contact: Marcia L Benedict
• Correspondent: Marcia L Benedict; STERIS Corporation 5960 Heisley Rd Mentor, OH 44060
• Product Code: NVE
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-16
• Decision Date: 2019-08-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00724995176730	K190081	000
00724995176723	K190081	000