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FDA 510(k)

OTOGRAM

K-Number: K041853 · 2004-09-03

ApplicantTympany, Inc.
Decision Date2004-09-03
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Tympany, Inc.. It received FDA 510(k) clearance on 2004-09-03 under 510(k) number K041853. 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 OTOGRAM?

OTOGRAM is a medical device that received FDA 510(k) clearance on 2004-09-03. The listed applicant is Tympany, Inc.. The 510(k) number is K041853.

When did OTOGRAM receive FDA 510(k) clearance?

OTOGRAM received FDA 510(k) clearance on 2004-09-03, under 510(k) number K041853.

Who is the listed applicant for OTOGRAM?

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

What is the FDA product code for OTOGRAM?

The FDA product code for OTOGRAM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tympany, 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.

K070118OTOGRAM, CA3350

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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