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FDA 510(k)

Acare Suction Unit

K-Number: K182950 · 2019-08-23

ApplicantAcare Technology Co., Ltd.
Decision Date2019-08-23
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Acare Suction Unit is the device name listed in this FDA 510(k) record. The listed applicant is Acare Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K182950. 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 Acare Suction Unit?

Acare Suction Unit is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Acare Technology Co., Ltd.. The 510(k) number is K182950.

When did Acare Suction Unit receive FDA 510(k) clearance?

Acare Suction Unit received FDA 510(k) clearance on 2019-08-23, under 510(k) number K182950.

Who is the listed applicant for Acare Suction Unit?

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

What is the FDA product code for Acare Suction Unit?

The FDA product code for Acare Suction Unit 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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