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FDA 510(k)

NASOPHARYNGOSCOPE, BRONCHOSCOPE

K-Number: K070580 · 2007-06-13

ApplicantXion GmbH
Decision Date2007-06-13
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NASOPHARYNGOSCOPE, BRONCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Xion GmbH. It received FDA 510(k) clearance on 2007-06-13 under 510(k) number K070580. 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 NASOPHARYNGOSCOPE, BRONCHOSCOPE?

NASOPHARYNGOSCOPE, BRONCHOSCOPE is a medical device that received FDA 510(k) clearance on 2007-06-13. The listed applicant is Xion GmbH. The 510(k) number is K070580.

When did NASOPHARYNGOSCOPE, BRONCHOSCOPE receive FDA 510(k) clearance?

NASOPHARYNGOSCOPE, BRONCHOSCOPE received FDA 510(k) clearance on 2007-06-13, under 510(k) number K070580.

Who is the listed applicant for NASOPHARYNGOSCOPE, BRONCHOSCOPE?

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

What is the FDA product code for NASOPHARYNGOSCOPE, BRONCHOSCOPE?

The FDA product code for NASOPHARYNGOSCOPE, BRONCHOSCOPE is EOB.

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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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