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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 the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2024-04-04 under 510(k) 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. The listed applicant is Midmark Corporation. The 510(k) number is K233026.

When did Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer receive FDA 510(k) clearance?

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

Who is the listed applicant for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

The FDA 510(k) record lists Midmark Corporation as the applicant. This does not by itself establish the device manufacturer.

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 records listing Midmark Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)K251626Midmark Dental Delivery SystemK201667Midmark Extraoral Imaging System (EOIS)K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerK161909IQvitals Zone

Related Devices (Code: FLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

Official Source

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

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