FEMTEST— 510(k) K844173

Substantially Equivalent

Bionexus, Inc.

FDA 510(k) clearance K844173 for FEMTEST, Substantially Equivalent on 1985-08-14. Applicant: Bionexus, Inc.. Device class: 2.

Clearance details

Applicant: Bionexus, Inc.
Product code: Code HES
Device class: Class 2
Regulation: 21 CFR 884.1300
Advisory panel: Obstetrics/Gynecology
Date received: 1984-10-25
Decision date: 1985-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, 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.