CLA-COMPUTERIZED LARYNGEAL ANALYZER— 510(k) K922553

Name: FDA 510(k) clearance K922553
Creator: U.S. Food and Drug Administration
Published: 1994-08-23

Substantially Equivalent

H.I.L. Research, Ltd.

FDA 510(k) clearance K922553 for CLA-COMPUTERIZED LARYNGEAL ANALYZER, Substantially Equivalent on 1994-08-23. Applicant: H.I.L. Research, Ltd.. Device class: 2.

Clearance details

Applicant: H.I.L. Research, Ltd.
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 1992-05-29
Decision date: 1994-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chico, CA, 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.