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FDA 510(k)

IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE

K-Number: K950983 · 1995-04-12

ApplicantIntrospect, Inc.
Decision Date1995-04-12
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Introspect, Inc.. It received FDA 510(k) clearance on 1995-04-12 under 510(k) number K950983. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE?

IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE is a medical device that received FDA 510(k) clearance on 1995-04-12. The listed applicant is Introspect, Inc.. The 510(k) number is K950983.

When did IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE receive FDA 510(k) clearance?

IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE received FDA 510(k) clearance on 1995-04-12, under 510(k) number K950983.

Who is the listed applicant for IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE?

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

What is the FDA product code for IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE?

The FDA product code for IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE is ERA.

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 Introspect, 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.

K951255IMEDGE VIDEO OSTOSCOPE (ANALOG)

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.

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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