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FDA 510(k)

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE

K-Number: K083861 · 2009-04-09

ApplicantInteracoustics AS
Decision Date2009-04-09
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics AS. It received FDA 510(k) clearance on 2009-04-09 under 510(k) number K083861. 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 TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE?

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE is a medical device that received FDA 510(k) clearance on 2009-04-09. The listed applicant is Interacoustics AS. The 510(k) number is K083861.

When did TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE receive FDA 510(k) clearance?

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE received FDA 510(k) clearance on 2009-04-09, under 510(k) number K083861.

Who is the listed applicant for TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE?

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

What is the FDA product code for TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE?

The FDA product code for TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE is ETY.

Related Clinical Trials

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Other records listing Interacoustics AS 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.

K090406EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULEK052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.K043219AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

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/SK081841AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETERAmplivox, Ltd.

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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