MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER— 510(k) K940426

Name: FDA 510(k) clearance K940426
Creator: U.S. Food and Drug Administration
Published: 1994-09-20

Substantially Equivalent

Medtronic Hemotec, Inc.

FDA 510(k) clearance K940426 for MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER, Substantially Equivalent on 1994-09-20. Applicant: Medtronic Hemotec, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Hemotec, Inc.
Product code: Code GKN
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 1994-01-31
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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