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FDA 510(k)

AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER

K-Number: K081841 · 2008-07-16

ApplicantAmplivox, Ltd.
Decision Date2008-07-16
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Amplivox, Ltd.. It received FDA 510(k) clearance on 2008-07-16 under 510(k) number K081841. 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 AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER?

AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER is a medical device that received FDA 510(k) clearance on 2008-07-16. The listed applicant is Amplivox, Ltd.. The 510(k) number is K081841.

When did AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER receive FDA 510(k) clearance?

AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER received FDA 510(k) clearance on 2008-07-16, under 510(k) number K081841.

Who is the listed applicant for AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER?

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

What is the FDA product code for AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER?

The FDA product code for AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER is ETY.

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Other records listing Amplivox, Ltd. 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.

K171265Otowave 302 Portable Tympanometer

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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