IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE— 510(k) K950983

Name: FDA 510(k) clearance K950983
Creator: U.S. Food and Drug Administration
Published: 1995-04-12

Substantially Equivalent

Introspect, Inc.

FDA 510(k) clearance K950983 for IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE, Substantially Equivalent on 1995-04-12. Applicant: Introspect, Inc.. Device class: 1.

Clearance details

Applicant: Introspect, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1995-03-03
Decision date: 1995-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Excelsior, MN, 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.