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)

THE LUOMANEN ORAL AIRWAY

K-Number: K810123 · 1981-02-26

ApplicantLuomanen Medical Products
Decision Date1981-02-26
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE LUOMANEN ORAL AIRWAY is the device name listed in this FDA 510(k) record. The listed applicant is Luomanen Medical Products. It received FDA 510(k) clearance on 1981-02-26 under 510(k) number K810123. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE LUOMANEN ORAL AIRWAY?

THE LUOMANEN ORAL AIRWAY is a medical device that received FDA 510(k) clearance on 1981-02-26. The listed applicant is Luomanen Medical Products. The 510(k) number is K810123.

When did THE LUOMANEN ORAL AIRWAY receive FDA 510(k) clearance?

THE LUOMANEN ORAL AIRWAY received FDA 510(k) clearance on 1981-02-26, under 510(k) number K810123.

Who is the listed applicant for THE LUOMANEN ORAL AIRWAY?

The FDA 510(k) record lists Luomanen Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE LUOMANEN ORAL AIRWAY?

The FDA product code for THE LUOMANEN ORAL AIRWAY is CAE.

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

Related Devices (Code: CAE)

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.

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305King Systems Corp.K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205King Systems Corp.K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp.K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)Mallinckrodt MedicalK960240RUSCH OPTOSAFERusch Intl.K950613KEISEIKeisei (Usa) Co., Ltd.

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.

↑