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FDA 510(k)

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer

K-Number: K163337 · 2017-08-31

ApplicantMidmark Corporation
Decision Date2017-08-31
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer is a medical device manufactured by Midmark Corporation. It received FDA 510(k) clearance on 2017-08-31 under approval number K163337. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer?

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Midmark Corporation. The 510(k) number is K163337.

When was Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer approved by the FDA?

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer received FDA 510(k) clearance on 2017-08-31, under approval number K163337.

What company makes Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer?

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer is manufactured by Midmark Corporation.

What is the FDA product code for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer?

The FDA product code for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer is FLE.

Other Devices by Midmark Corporation

K161909IQvitals Zone K201667Midmark Extraoral Imaging System (EOIS) K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer K251626Midmark Dental Delivery System

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L. K173481Amsco Evolution Medium Steam SterilizerSTERIS Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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