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FDA 510(k)

MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM

K-Number: K872633 · 1987-09-16

ApplicantHearing Health Care Program
Decision Date1987-09-16
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Health Care Program. It received FDA 510(k) clearance on 1987-09-16 under 510(k) number K872633. 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 MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM?

MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM is a medical device that received FDA 510(k) clearance on 1987-09-16. The listed applicant is Hearing Health Care Program. The 510(k) number is K872633.

When did MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM receive FDA 510(k) clearance?

MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM received FDA 510(k) clearance on 1987-09-16, under 510(k) number K872633.

Who is the listed applicant for MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM?

The FDA 510(k) record lists Hearing Health Care Program as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM?

The FDA product code for MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM 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.

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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.

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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