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FDA 510(k)

IMEDGE VIDEO OSTOSCOPE (ANALOG)

K-Number: K951255 · 1995-04-13

ApplicantIntrospect, Inc.
Decision Date1995-04-13
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IMEDGE VIDEO OSTOSCOPE (ANALOG) is the device name listed in this FDA 510(k) record. The listed applicant is Introspect, Inc.. It received FDA 510(k) clearance on 1995-04-13 under 510(k) number K951255. 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 VIDEO OSTOSCOPE (ANALOG)?

IMEDGE VIDEO OSTOSCOPE (ANALOG) is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Introspect, Inc.. The 510(k) number is K951255.

When did IMEDGE VIDEO OSTOSCOPE (ANALOG) receive FDA 510(k) clearance?

IMEDGE VIDEO OSTOSCOPE (ANALOG) received FDA 510(k) clearance on 1995-04-13, under 510(k) number K951255.

Who is the listed applicant for IMEDGE VIDEO OSTOSCOPE (ANALOG)?

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 VIDEO OSTOSCOPE (ANALOG)?

The FDA product code for IMEDGE VIDEO OSTOSCOPE (ANALOG) 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.

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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.

K950983IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE

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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