FDA 510(k)

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

Numéro K : K163337 · 2017-08-31

Date de décision2017-08-31

Code produitFLE

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Midmark Corporation. The 510(k) number is K163337.

When did Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer receive FDA 510(k) clearance?

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 510(k) number K163337.

Who is the listed applicant for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic 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 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.

Essais cliniques associés

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Autres dossiers indiquant Midmark Corporation en tant que demandeur

K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)K251626Midmark Dental Delivery System K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer K201667Midmark Extraoral Imaging System (EOIS)K161909IQvitals Zone

Dispositifs connexes (Code : FLE)

K261055AMSCO 700 Steam SterilizerSTERIS Corporation K260254Enbio PROEnbio Group AG K252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare K250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

Source officielle

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