HOME CARE EAR EXAMINATIO KIT— 510(k) K944897

Name: FDA 510(k) clearance K944897
Creator: U.S. Food and Drug Administration
Published: 1994-11-08

Substantially Equivalent

Home Care Instruments, Inc.

FDA 510(k) clearance K944897 for HOME CARE EAR EXAMINATIO KIT, Substantially Equivalent on 1994-11-08. Applicant: Home Care Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Home Care Instruments, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1994-10-04
Decision date: 1994-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERA

view all

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.