HORTMANN AIRMATIC AIR CALORIC STIMULATOR— 510(k) K950785

Name: FDA 510(k) clearance K950785
Creator: U.S. Food and Drug Administration
Published: 1995-06-28

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K950785 for HORTMANN AIRMATIC AIR CALORIC STIMULATOR, Substantially Equivalent on 1995-06-28. Applicant: Jedmed Instrument Co.. Device class: 1.

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code KHH
Device class: Class 1
Regulation: 21 CFR 874.1800
Advisory panel: Ear, Nose, Throat
Date received: 1995-02-21
Decision date: 1995-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.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.