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FDA 510(k)

GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM

K-Number: K934342 · 1994-01-21

ApplicantGlaser Instruments AG
Decision Date1994-01-21
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Glaser Instruments AG. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K934342. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM?

GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Glaser Instruments AG. The 510(k) number is K934342.

When did GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM receive FDA 510(k) clearance?

GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM received FDA 510(k) clearance on 1994-01-21, under 510(k) number K934342.

Who is the listed applicant for GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM?

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

What is the FDA product code for GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM?

The FDA product code for GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM is ETW.

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 Glaser Instruments AG 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.

K934343GLASER RT60, RT80, RT150 AUDIOMETER

Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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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