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FDA 510(k)

ER-7C CLINICAL PROBE MICROPHONE

K-Number: K861113 · 1986-04-23

ApplicantEtymotic Research
Decision Date1986-04-23
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ER-7C CLINICAL PROBE MICROPHONE is the device name listed in this FDA 510(k) record. The listed applicant is Etymotic Research. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K861113. 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 ER-7C CLINICAL PROBE MICROPHONE?

ER-7C CLINICAL PROBE MICROPHONE is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Etymotic Research. The 510(k) number is K861113.

When did ER-7C CLINICAL PROBE MICROPHONE receive FDA 510(k) clearance?

ER-7C CLINICAL PROBE MICROPHONE received FDA 510(k) clearance on 1986-04-23, under 510(k) number K861113.

Who is the listed applicant for ER-7C CLINICAL PROBE MICROPHONE?

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

What is the FDA product code for ER-7C CLINICAL PROBE MICROPHONE?

The FDA product code for ER-7C CLINICAL PROBE MICROPHONE is ETW.

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Other records listing Etymotic Research 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.

K011114ETYMOTIC RESEARCH ER-10D OAE PROBEK010165ERO SCAN OAE TEST SYSTEMK980533ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENTK930003TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONESK873298ELEC-TIP

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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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