IONOMETER E-HK AND ACCESSORIES— 510(k) K880373

Name: FDA 510(k) clearance K880373
Creator: U.S. Food and Drug Administration
Published: 1988-03-17

Substantially Equivalent

Smash Ent., Inc.

FDA 510(k) clearance K880373 for IONOMETER E-HK AND ACCESSORIES, Substantially Equivalent on 1988-03-17. Applicant: Smash Ent., Inc.. Device class: 2.

Clearance details

Applicant: Smash Ent., Inc.
Product code: Code GKF
Device class: Class 2
Regulation: 21 CFR 864.5600
Advisory panel: Hematology
Date received: 1988-01-27
Decision date: 1988-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.