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)

AUDIOMETERS (VARIOUS MODELS)

K-Number: K822177 · 1982-08-25

ApplicantKelleher Corp.
Decision Date1982-08-25
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AUDIOMETERS (VARIOUS MODELS) is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-08-25 under 510(k) number K822177. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIOMETERS (VARIOUS MODELS)?

AUDIOMETERS (VARIOUS MODELS) is a medical device that received FDA 510(k) clearance on 1982-08-25. The listed applicant is Kelleher Corp.. The 510(k) number is K822177.

When did AUDIOMETERS (VARIOUS MODELS) receive FDA 510(k) clearance?

AUDIOMETERS (VARIOUS MODELS) received FDA 510(k) clearance on 1982-08-25, under 510(k) number K822177.

Who is the listed applicant for AUDIOMETERS (VARIOUS MODELS)?

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

What is the FDA product code for AUDIOMETERS (VARIOUS MODELS)?

The FDA product code for AUDIOMETERS (VARIOUS MODELS) is GWJ.

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 Kelleher Corp. 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.

K822618EMERGENCY TRACHEOSTOMY INSTRUMENT SETK822268NAGASHIMA NS-III ELECTRONYSTAGMOGRAPHK823083ELECTROSURGICAL UNITK822252ENT TREATMENT UNITSK823111NYSTYMOGRAPH ACCESSK822272HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS

View all 94 devices →

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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.

↑