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FDA 510(k)

PERSONAL HEARING SYSTEM

K-Number: K944041 · 1994-12-27

ApplicantResound Corp.
Decision Date1994-12-27
Product CodeLRS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERSONAL HEARING 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 1994-12-27 under 510(k) number K944041. The device is classified under product code LRS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONAL HEARING SYSTEM?

PERSONAL HEARING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Resound Corp.. The 510(k) number is K944041.

When did PERSONAL HEARING SYSTEM receive FDA 510(k) clearance?

PERSONAL HEARING SYSTEM received FDA 510(k) clearance on 1994-12-27, under 510(k) number K944041.

Who is the listed applicant for PERSONAL HEARING 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 PERSONAL HEARING SYSTEM?

The FDA product code for PERSONAL HEARING SYSTEM is LRS.

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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 AIDSK974081RESOUND STEALTH CICK974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)K971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONK970215AUDALLION II HEARING SYSTEMK964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

View all 41 devices →

Related Devices (Code: LRS)

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.

K050654AMSINO I.V. START KITAmsino International, Inc.K001879INFUSION IV SETNirvi Intl. USAK963722IV START KITGrand Medical ProductsK951167EMS I.V. START KITEmergency Medical Supply, Inc.K950184B. BRAUN IV START KITSB. Braun of America, Inc.K943941SAFESTART VASCULAR ACCESS START KITBecton Dickinson Vascular Access, 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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