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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 a medical device manufactured by Taiwan Biomaterial Co., Ltd.. It received FDA 510(k) clearance on 2018-07-24 under approval 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. It is manufactured by Taiwan Biomaterial Co., Ltd.. The 510(k) number is K180115.

When was TWBM Pump approved by the FDA?

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

What company makes TWBM Pump?

TWBM Pump is manufactured by Taiwan Biomaterial Co., Ltd..

What is the FDA product code for TWBM Pump?

The FDA product code for TWBM Pump is JCX.

Other Devices by Taiwan Biomaterial Co., Ltd.

K190105ZOOM Aspiration Pump

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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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