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FDA 510(k)

CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V

K-Number: K082038 · 2009-04-28

ApplicantClarus Medical, LLC
Decision Date2009-04-28
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2009-04-28 under 510(k) number K082038. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V?

CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V is a medical device that received FDA 510(k) clearance on 2009-04-28. The listed applicant is Clarus Medical, LLC. The 510(k) number is K082038.

When did CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V receive FDA 510(k) clearance?

CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V received FDA 510(k) clearance on 2009-04-28, under 510(k) number K082038.

Who is the listed applicant for CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V?

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

What is the FDA product code for CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V?

The FDA product code for CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V is BTR.

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Related Devices (Code: BTR)

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

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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