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FDA 510(k)

ZOOM Aspiration Pump

K-Number: K190105 · 2019-02-21

ApplicantTaiwan Biomaterial Co., Ltd.
Decision Date2019-02-21
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZOOM Aspiration Pump is a medical device manufactured by Taiwan Biomaterial Co., Ltd.. It received FDA 510(k) clearance on 2019-02-21 under approval number K190105. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOOM Aspiration Pump?

ZOOM Aspiration Pump is a medical device that received FDA 510(k) clearance on 2019-02-21. It is manufactured by Taiwan Biomaterial Co., Ltd.. The 510(k) number is K190105.

When was ZOOM Aspiration Pump approved by the FDA?

ZOOM Aspiration Pump received FDA 510(k) clearance on 2019-02-21, under approval number K190105.

What company makes ZOOM Aspiration Pump?

ZOOM Aspiration Pump is manufactured by Taiwan Biomaterial Co., Ltd..

What is the FDA product code for ZOOM Aspiration Pump?

The FDA product code for ZOOM Aspiration Pump is JCX.

Other Devices by Taiwan Biomaterial Co., Ltd.

K180115TWBM Pump

Related Devices (Code: JCX)

K162421IntelliCartTM SystemDornoch Medical Systems K153407Stryker Neptune 3 Waste Management SystemStryker Corporation K172481IntelliCart SystemDornoch Medical Systems K161358Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. K180115TWBM PumpTaiwan Biomaterial Co., Ltd. K181398DV-300 AspiratorDing Hwa 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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