ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM— 510(k) K132039

Name: FDA 510(k) clearance K132039
Creator: U.S. Food and Drug Administration
Published: 2014-02-21

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K132039 for ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM, Substantially Equivalent on 2014-02-21. Applicant: Jedmed Instrument Co.. Device class: 2.

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code EQN
Device class: Class 2
Regulation: 21 CFR 874.4760
Advisory panel: Ear, Nose, Throat
Date received: 2013-07-02
Decision date: 2014-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.