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FDA 510(k)

TWBM Pump

K-Number: K180115 · 2018-07-24

ApplicantTaiwan Biomaterial Co., Ltd.
Decision Date2018-07-24
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TWBM Pump is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Biomaterial Co., Ltd.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K180115. 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 TWBM Pump?

TWBM Pump is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Taiwan Biomaterial Co., Ltd.. The 510(k) number is K180115.

When did TWBM Pump receive FDA 510(k) clearance?

TWBM Pump received FDA 510(k) clearance on 2018-07-24, under 510(k) number K180115.

Who is the listed applicant for TWBM Pump?

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

What is the FDA product code for TWBM Pump?

The FDA product code for TWBM Pump is JCX.

Other records listing Taiwan Biomaterial 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.

K190105ZOOM Aspiration Pump

Related Devices (Code: JCX)

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.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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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