BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM— 510(k) K954501

Name: FDA 510(k) clearance K954501
Creator: U.S. Food and Drug Administration
Published: 1996-01-16

Substantially Equivalent

Medtronic Bio-Medicus, Inc.

FDA 510(k) clearance K954501 for BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM, Substantially Equivalent on 1996-01-16. Applicant: Medtronic Bio-Medicus, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Bio-Medicus, Inc.
Product code: Code DTY
Device class: Class 2
Regulation: 21 CFR 870.4410
Advisory panel: Cardiovascular
Date received: 1995-09-28
Decision date: 1996-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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