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FDA 510(k)

AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500

K-Number: K884046 · 1989-02-13

ApplicantEtymonic Design, Inc.
Decision Date1989-02-13
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 is the device name listed in this FDA 510(k) record. The listed applicant is Etymonic Design, Inc.. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K884046. 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 AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500?

AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Etymonic Design, Inc.. The 510(k) number is K884046.

When did AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 receive FDA 510(k) clearance?

AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 received FDA 510(k) clearance on 1989-02-13, under 510(k) number K884046.

Who is the listed applicant for AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500?

The FDA 510(k) record lists Etymonic Design, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500?

The FDA product code for AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 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 Etymonic Design, 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.

K012306AUDIOSCAN VERIFIT, MODEL VF-1

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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