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FDA 510(k)

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

K-Number: K990189 · 1999-04-19

ApplicantMidmark Corp.
Decision Date1999-04-19
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corp.. It received FDA 510(k) clearance on 1999-04-19 under 510(k) number K990189. 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 MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER?

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER is a medical device that received FDA 510(k) clearance on 1999-04-19. The listed applicant is Midmark Corp.. The 510(k) number is K990189.

When did MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER receive FDA 510(k) clearance?

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER received FDA 510(k) clearance on 1999-04-19, under 510(k) number K990189.

Who is the listed applicant for MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER?

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

What is the FDA product code for MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER?

The FDA product code for MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER is FLE.

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Other records listing Midmark Corp. 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.

K122643VANTAGE MODEL V5000, V5100, V5000C, V5100CK112380CLEARVISIONK090670MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZERK023348MIDMARK M9 ULTRACLAVE STEAM STERILIZERK003090MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEMK992744MIDMARK M4*9 EASYCLAVE STEAM STERILIZER

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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

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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