Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OXYGEN CATHETERS

K-Number: K830984 · 1983-05-18

ApplicantMedovations, Inc.
Decision Date1983-05-18
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 Medovations, Inc.. It received FDA 510(k) clearance on 1983-05-18 under 510(k) number K830984. 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 1983-05-18. The listed applicant is Medovations, Inc.. The 510(k) number is K830984.

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

OXYGEN CATHETERS received FDA 510(k) clearance on 1983-05-18, under 510(k) number K830984.

Who is the listed applicant for OXYGEN CATHETERS?

The FDA 510(k) record lists Medovations, Inc. 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 Medovations, Inc. 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.

K002363MEDOVATIONS ESOPHAGEAL DILATORK972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)K924646OVER THE GUIDEWIRE DILATATION SYSTEMK913678TROCAR CATHETERK905478YANKAUER SUCTION DEVICEK874309URETHAL CATHETER

View all 30 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.

K896731OXYGEN CATHETERSUnoplast A/SK843466PHARMA-PLAST OXYGEN CATHETERZimmar Consulting , Ltd.K833351DEMAND OXYGEN CONTROLLERHealthdyne, 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.

↑