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)

MAXAIR NASAL DILATOR SYSTEM

K-Number: K982929 · 1998-09-09

ApplicantHnl Technologies
Decision Date1998-09-09
Product CodeLWF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MAXAIR NASAL DILATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hnl Technologies. It received FDA 510(k) clearance on 1998-09-09 under 510(k) number K982929. The device is classified under product code LWF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXAIR NASAL DILATOR SYSTEM?

MAXAIR NASAL DILATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-09. The listed applicant is Hnl Technologies. The 510(k) number is K982929.

When did MAXAIR NASAL DILATOR SYSTEM receive FDA 510(k) clearance?

MAXAIR NASAL DILATOR SYSTEM received FDA 510(k) clearance on 1998-09-09, under 510(k) number K982929.

Who is the listed applicant for MAXAIR NASAL DILATOR SYSTEM?

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

What is the FDA product code for MAXAIR NASAL DILATOR SYSTEM?

The FDA product code for MAXAIR NASAL DILATOR SYSTEM is LWF.

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: LWF)

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.

K181219OptiPillows EPAP MaskCpapnea Medical SupplyK120665INVENT SNORING DEVICEVentus Medical, Inc.K040491CHIN-UP STRIPDale Miller, Inc. - the Chin-Up CompanyK963326BREATHE FITCambridge Assoc.K962400AIR MAX EXTERNAL NASAL DILATOR STRIPAmerican White Cross, Inc.K962698ACUTEK'S CLEARPASAGEAcutek Adhesive Specialties, 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.

↑