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FDA 510(k)

Andorate Auxiliary Water Connector, Andorate Valves Set

K-Number: K191231 · 2019-06-07

ApplicantSmartdata Suzhou Co., Ltd.
Decision Date2019-06-07
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Andorate Auxiliary Water Connector, Andorate Valves Set is the device name listed in this FDA 510(k) record. The listed applicant is Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K191231. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Andorate Auxiliary Water Connector, Andorate Valves Set?

Andorate Auxiliary Water Connector, Andorate Valves Set is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Smartdata Suzhou Co., Ltd.. The 510(k) number is K191231.

When did Andorate Auxiliary Water Connector, Andorate Valves Set receive FDA 510(k) clearance?

Andorate Auxiliary Water Connector, Andorate Valves Set received FDA 510(k) clearance on 2019-06-07, under 510(k) number K191231.

Who is the listed applicant for Andorate Auxiliary Water Connector, Andorate Valves Set?

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

What is the FDA product code for Andorate Auxiliary Water Connector, Andorate Valves Set?

The FDA product code for Andorate Auxiliary Water Connector, Andorate Valves Set is ODC.

Other records listing Smartdata Suzhou 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.

K191366Vacutore Air/Water Bottle TubingK182998Andorate Auxiliary Water ConnectorK181509Endorate Valve Sets

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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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