FRITCH OPHTHALMIC ENDOSCOPE— 510(k) K855151

Substantially Equivalent

Regtec

FDA 510(k) clearance K855151 for FRITCH OPHTHALMIC ENDOSCOPE, Substantially Equivalent on 1986-02-19. Applicant: Regtec. Device class: 2.

Clearance details

Applicant: Regtec
Product code: Code GDB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1985-12-26
Decision date: 1986-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDB

K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT2003-08-20
K961536 — FLEXSCOPE1996-09-18
K935818 — ENDOSCOPE1994-07-13
K882061 — OLYMPUS GF-UM3/EU-M31988-11-15
K843900 — FOCUSCOPE UNIVERSAL SYSTEM1984-12-06

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