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FDA 510(k)

RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE

K-Number: K894019 · 1989-09-21

ApplicantResound Corp.
Decision Date1989-09-21
Product CodeKHL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE is the device name listed in this FDA 510(k) record. The listed applicant is Resound Corp.. It received FDA 510(k) clearance on 1989-09-21 under 510(k) number K894019. The device is classified under product code KHL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE?

RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE is a medical device that received FDA 510(k) clearance on 1989-09-21. The listed applicant is Resound Corp.. The 510(k) number is K894019.

When did RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE receive FDA 510(k) clearance?

RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE received FDA 510(k) clearance on 1989-09-21, under 510(k) number K894019.

Who is the listed applicant for RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE?

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 DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE?

The FDA product code for RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE is KHL.

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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

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Related Devices (Code: KHL)

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.

K964080LORI HEARING AID SIMULATORLori Medical Laboratories, Inc.K911726PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATIONBausch & Lomb, Inc.K860171VOROBA PROGRAMMABLE AUDITORY COMPARATORVoroba Technologies Assoc.K854126CRAIGWELL MASTER HEARING AID MHACraigwell Electronics, Ltd.K802812RIONET HEARING AIDKindel & AndersonK790481MODEL FS1Starkey Laboratories, 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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