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FDA 510(k)

ENDECO ACOUSTIC OTOSCOPE

K-Number: K830139 · 1983-03-09

ApplicantEndeco Medical, Inc.
Decision Date1983-03-09
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENDECO ACOUSTIC OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Endeco Medical, Inc.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830139. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDECO ACOUSTIC OTOSCOPE?

ENDECO ACOUSTIC OTOSCOPE is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Endeco Medical, Inc.. The 510(k) number is K830139.

When did ENDECO ACOUSTIC OTOSCOPE receive FDA 510(k) clearance?

ENDECO ACOUSTIC OTOSCOPE received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830139.

Who is the listed applicant for ENDECO ACOUSTIC OTOSCOPE?

The FDA 510(k) record lists Endeco Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDECO ACOUSTIC OTOSCOPE?

The FDA product code for ENDECO ACOUSTIC OTOSCOPE is ETY.

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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Other records listing Endeco Medical, Inc. 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.

K850007ACOUSTIC OTOCOPE RECORDER

Related Devices (Code: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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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