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FDA 510(k)

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

K-Number: K200388 · 2020-04-14

ApplicantGa Health Company Limited
Decision Date2020-04-14
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K200388. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Ga Health Company Limited. The 510(k) number is K200388.

When did Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector receive FDA 510(k) clearance?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector received FDA 510(k) clearance on 2020-04-14, under 510(k) number K200388.

Who is the listed applicant for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

The FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is OCX.

Other records listing Ga Health Company Limited as applicant

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Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, Inc.

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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