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FDA 510(k)

Oxyless Blood Tubing Set

K-Number: K150304 · 2016-02-24

ApplicantOxyless, Ltd.
Decision Date2016-02-24
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Oxyless Blood Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Oxyless, Ltd.. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K150304. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxyless Blood Tubing Set?

Oxyless Blood Tubing Set is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Oxyless, Ltd.. The 510(k) number is K150304.

When did Oxyless Blood Tubing Set receive FDA 510(k) clearance?

Oxyless Blood Tubing Set received FDA 510(k) clearance on 2016-02-24, under 510(k) number K150304.

Who is the listed applicant for Oxyless Blood Tubing Set?

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

What is the FDA product code for Oxyless Blood Tubing Set?

The FDA product code for Oxyless Blood Tubing Set is FJK.

Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, Inc.

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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