MODEL 3000 OPTICATH COMPUTER— 510(k) K853018

Substantially Equivalent

Oximetrix, Inc.

FDA 510(k) clearance K853018 for MODEL 3000 OPTICATH COMPUTER, Substantially Equivalent on 1986-01-13. Applicant: Oximetrix, Inc.. Device class: 2.

Clearance details

Applicant: Oximetrix, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1985-07-17
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Oximetrix, Inc.

K842622 — HEMO STATIC/ESU SCALPEL SYSTEM1984-10-23
K833966 — PUMP INFUSION WEARABLE INFUSION PUMP1984-01-25
K823007 — OPTICATH HEPARIN COATED, FLOW-DIRECT1982-11-01
K821056 — FLOW DIRECTED THERMAL-DILUTION CATHETER1982-05-18
K821057 — FLOW DIRECTED THERMAL-DILUTION INFUSION1982-05-18

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