EARSCOPE— 510(k) K800365

Substantially Equivalent

Nash & Assoc.

FDA 510(k) clearance K800365 for EARSCOPE, Substantially Equivalent on 1980-03-10. Applicant: Nash & Assoc.. Device class: 1.

Clearance details

Applicant: Nash & Assoc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1980-02-20
Decision date: 1980-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERA

K123821 — AIO HD OTOSCOPE2013-05-17
K121326 — LANTOS 3D EAR SCANNER2013-01-25
K110326 — OSRAM ITOS2011-10-27
K945264 — OPTUS OTOSCOPES1996-02-02
K955043 — WELCH ALLYN BI-OTOSCOPE1995-11-14

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