INSPETOSCOPE— 510(k) K831614

Substantially Equivalent

Terayco Intl., Ltd.

FDA 510(k) clearance K831614 for INSPETOSCOPE, Substantially Equivalent on 1983-08-12. Applicant: Terayco Intl., Ltd.. Device class: 1.

Clearance details

Applicant: Terayco Intl., Ltd.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1983-05-19
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERA

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K110326 — OSRAM ITOS2011-10-27
K945264 — OPTUS OTOSCOPES1996-02-02
K955043 — WELCH ALLYN BI-OTOSCOPE1995-11-14

More clearances from Terayco Intl., Ltd.

K844624 — BASIS DIGITAL THERMOMETER MODEL BTM-11985-03-21
K831929 — BASIC BREAST PUMP1983-09-29

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