NO. 100352 GALVANIC OXYGEN SENSOR— 510(k) K862113

Name: FDA 510(k) clearance K862113
Creator: U.S. Food and Drug Administration
Published: 1986-06-19

Substantially Equivalent

Vascular Technology Incorporated

FDA 510(k) clearance K862113 for NO. 100352 GALVANIC OXYGEN SENSOR, Substantially Equivalent on 1986-06-19. Applicant: Vascular Technology Incorporated. Device class: 2.

Clearance details

Applicant: Vascular Technology Incorporated
Product code: Code CCL
Device class: Class 2
Regulation: 21 CFR 868.1720
Advisory panel: Anesthesiology
Date received: 1986-06-03
Decision date: 1986-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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K250002 — Smart Check O2 (MA0236)2025-04-24
K221734 — Maxtec MaxO2 ME+p2023-04-01
K213933 — Percent Oxygen Sensors2022-08-19

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K944764 — VTI DISPOSABLE PRESSURE DISPLAY SET1994-12-27
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Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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