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FDA 510(k)

DV-300 Aspirator

K-Number: K181398 · 2018-07-23

ApplicantDing Hwa Co., Ltd.
Decision Date2018-07-23
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DV-300 Aspirator is the device name listed in this FDA 510(k) record. The listed applicant is Ding Hwa Co., Ltd.. It received FDA 510(k) clearance on 2018-07-23 under 510(k) number K181398. 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 DV-300 Aspirator?

DV-300 Aspirator is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Ding Hwa Co., Ltd.. The 510(k) number is K181398.

When did DV-300 Aspirator receive FDA 510(k) clearance?

DV-300 Aspirator received FDA 510(k) clearance on 2018-07-23, under 510(k) number K181398.

Who is the listed applicant for DV-300 Aspirator?

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

What is the FDA product code for DV-300 Aspirator?

The FDA product code for DV-300 Aspirator is JCX.

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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