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FDA 510(k)

RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1

K-Number: K922570 · 1992-08-06

ApplicantResound Corp.
Decision Date1992-08-06
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 is the device name listed in this FDA 510(k) record. The listed applicant is Resound Corp.. It received FDA 510(k) clearance on 1992-08-06 under 510(k) number K922570. The device is classified under product code EPF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1?

RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 is a medical device that received FDA 510(k) clearance on 1992-08-06. The listed applicant is Resound Corp.. The 510(k) number is K922570.

When did RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 receive FDA 510(k) clearance?

RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 received FDA 510(k) clearance on 1992-08-06, under 510(k) number K922570.

Who is the listed applicant for RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1?

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 PERSONAL HEARING SYSTEM SOUNDLINK-1?

The FDA product code for RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 is EPF.

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Other records listing Resound 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.

K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDSK974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)K974081RESOUND STEALTH CICK971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONK970215AUDALLION II HEARING SYSTEMK964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

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Related Devices (Code: EPF)

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.

K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONTelex Communications, Inc.K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, ITPhonic Ear, Inc.K974287FM RECEIVER - AUDITORY TRAINERPhonic Ear, Inc.K970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK960567HF MEGA EARMaxi-Aids, 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.

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