HEPCON HMS WITH BODY SURFACE AREA CALCULATION— 510(k) K911240

Name: FDA 510(k) clearance K911240
Creator: U.S. Food and Drug Administration
Published: 1991-07-17

Substantially Equivalent

Hemotech, Inc.

FDA 510(k) clearance K911240 for HEPCON HMS WITH BODY SURFACE AREA CALCULATION, Substantially Equivalent on 1991-07-17. Applicant: Hemotech, Inc.. Device class: 2.

Clearance details

Applicant: Hemotech, Inc.
Product code: Code JOX
Device class: Class 2
Regulation: 21 CFR 864.5680
Advisory panel: Hematology
Date received: 1991-03-21
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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