HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT— 510(k) K822823

Name: FDA 510(k) clearance K822823
Creator: U.S. Food and Drug Administration
Published: 1982-10-18

Substantially Equivalent

Eko Scann AB

FDA 510(k) clearance K822823 for HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT, Substantially Equivalent on 1982-10-18. Applicant: Eko Scann AB. Device class: 2.

Clearance details

Applicant: Eko Scann AB
Product code: Code LKM
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1982-09-21
Decision date: 1982-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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