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FDA 510(k)

RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM

K-Number: K960229 · 1996-03-07

ApplicantResound Corp.
Decision Date1996-03-07
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Resound Corp.. It received FDA 510(k) clearance on 1996-03-07 under 510(k) number K960229. 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 RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM?

RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-07. The listed applicant is Resound Corp.. The 510(k) number is K960229.

When did RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM receive FDA 510(k) clearance?

RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM received FDA 510(k) clearance on 1996-03-07, under 510(k) number K960229.

Who is the listed applicant for RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM?

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

What is the FDA product code for RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM?

The FDA product code for RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM is ETW.

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Other records listing Resound Corp. as applicant

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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.

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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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