Cleared Traditional

K862113 - NO. 100352 GALVANIC OXYGEN SENSOR (FDA 510(k) Clearance)

K862113 · Vascular Technology Incorporated · Anesthesiology device

Jun 1986

Decision

16d

Days

Class 2

Risk

K862113 is an FDA 510(k) clearance for the NO. 100352 GALVANIC OXYGEN SENSOR. This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).

Submitted by Vascular Technology Incorporated (Attleboro, US). The FDA issued a Cleared decision on June 19, 1986, 16 days after receiving the submission on June 3, 1986.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number	K862113 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 03, 1986
Decision Date	June 19, 1986
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—