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FDA 510(k)

ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105

K-Number: K080622 · 2008-04-02

ApplicantOptim, Inc.
Decision Date2008-04-02
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 is the device name listed in this FDA 510(k) record. The listed applicant is Optim, Inc.. It received FDA 510(k) clearance on 2008-04-02 under 510(k) number K080622. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105?

ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 is a medical device that received FDA 510(k) clearance on 2008-04-02. The listed applicant is Optim, Inc.. The 510(k) number is K080622.

When did ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 receive FDA 510(k) clearance?

ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 received FDA 510(k) clearance on 2008-04-02, under 510(k) number K080622.

Who is the listed applicant for ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105?

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

What is the FDA product code for ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105?

The FDA product code for ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 is EOB.

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Other records listing Optim, 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.

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Related Devices (Code: EOB)

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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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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