OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)— 510(k) K951806

Name: FDA 510(k) clearance K951806
Creator: U.S. Food and Drug Administration
Published: 1995-07-06

Substantially Equivalent

Opgal Optronic Industries

FDA 510(k) clearance K951806 for OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000), Substantially Equivalent on 1995-07-06. Applicant: Opgal Optronic Industries. Device class: 1.

Clearance details

Applicant: Opgal Optronic Industries
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1995-04-19
Decision date: 1995-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHQ

view all

K253911 — Derma-22026-05-20
K232462 — ThermPix Thermovisual Camera2023-09-14
K213650 — ThermPix Thermovisual Camera2022-04-12
K212965 — Smile-100 System2022-03-10
K212412 — IRIS-XP2021-09-13

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