HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX— 510(k) K101271

Name: FDA 510(k) clearance K101271
Creator: U.S. Food and Drug Administration
Published: 2010-10-13

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K101271 for HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX, Substantially Equivalent on 2010-10-13. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code JOX
Device class: Class 2
Regulation: 21 CFR 864.5680
Advisory panel: Hematology
Date received: 2010-05-06
Decision date: 2010-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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