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FDA 510(k)

SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG

K-Number: K122774 · 2013-05-09

ApplicantSakura Seiki Co., Ltd.
Decision Date2013-05-09
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG is the device name listed in this FDA 510(k) record. The listed applicant is Sakura Seiki Co., Ltd.. It received FDA 510(k) clearance on 2013-05-09 under 510(k) number K122774. 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 SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG?

SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG is a medical device that received FDA 510(k) clearance on 2013-05-09. The listed applicant is Sakura Seiki Co., Ltd.. The 510(k) number is K122774.

When did SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG receive FDA 510(k) clearance?

SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG received FDA 510(k) clearance on 2013-05-09, under 510(k) number K122774.

Who is the listed applicant for SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG?

The FDA 510(k) record lists Sakura Seiki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG?

The FDA product code for SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG is FLE.

Related Clinical Trials

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.

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Other records listing Sakura Seiki Co., Ltd. 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.

K120149SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA

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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