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FDA 510(k)

OXYGEN CATHETERS

K-Number: K896731 · 1990-03-30

ApplicantUnoplast A/S
Decision Date1990-03-30
Product CodeBZB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Unoplast A/S. It received FDA 510(k) clearance on 1990-03-30 under 510(k) number K896731. The device is classified under product code BZB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN CATHETERS?

OXYGEN CATHETERS is a medical device that received FDA 510(k) clearance on 1990-03-30. The listed applicant is Unoplast A/S. The 510(k) number is K896731.

When did OXYGEN CATHETERS receive FDA 510(k) clearance?

OXYGEN CATHETERS received FDA 510(k) clearance on 1990-03-30, under 510(k) number K896731.

Who is the listed applicant for OXYGEN CATHETERS?

The FDA 510(k) record lists Unoplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYGEN CATHETERS?

The FDA product code for OXYGEN CATHETERS is BZB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Unoplast A/S as applicant

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.

K896734FEEDING TUBEK896729NELATON-, FEMALE - OR TIEMANN CATHETERK896732UNOMETER 500K896730SUCTION CATHETER STRAIGHT/COUDEK896733VACCONK802248DISARP ORIGINAL

View all 7 devices →

Related Devices (Code: BZB)

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.

K843466PHARMA-PLAST OXYGEN CATHETERZimmar Consulting , Ltd.K833351DEMAND OXYGEN CONTROLLERHealthdyne, Inc.K830984OXYGEN CATHETERSMedovations, Inc.K820370NASAL OXYGEN CATHETERAmerican Pharmaseal Div. AhscK800506OXYGEN CATHETERMedi-Craft , Ltd.K791273CONPHAR OXYGEN CATHETER-STERILEConphar, 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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