M-LENS (THIRTY DEGREE ENDOSCOPE)— 510(k) K873795

Name: FDA 510(k) clearance K873795
Creator: U.S. Food and Drug Administration
Published: 1988-01-14

Substantially Equivalent

Opto Vision, Inc.

FDA 510(k) clearance K873795 for M-LENS (THIRTY DEGREE ENDOSCOPE), Substantially Equivalent on 1988-01-14. Applicant: Opto Vision, Inc.. Device class: 1.

Clearance details

Applicant: Opto Vision, Inc.
Product code: Code FEI
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1987-09-17
Decision date: 1988-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FEI

view all

K862872 — FLEXIBLE VISUALIZATION CATHETER1986-10-24

More clearances from Opto Vision, Inc.

view all

K892145 — FIBER OPTIC LIGHT TRANSMISSION CABLE1989-09-29

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