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FDA 510(k)

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer

K-Number: K233026 · 2024-04-04

ApplicantMidmark Corporation
Decision Date2024-04-04
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is a medical device manufactured by Midmark Corporation. It received FDA 510(k) clearance on 2024-04-04 under approval number K233026. 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 Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is a medical device that received FDA 510(k) clearance on 2024-04-04. It is manufactured by Midmark Corporation. The 510(k) number is K233026.

When was Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer approved by the FDA?

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer received FDA 510(k) clearance on 2024-04-04, under approval number K233026.

What company makes Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is manufactured by Midmark Corporation.

What is the FDA product code for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

The FDA product code for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is FLE.

Other Devices by Midmark Corporation

K161909IQvitals Zone K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer K201667Midmark Extraoral Imaging System (EOIS) K251626Midmark Dental Delivery System

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation 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.

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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