APTEK ULTRASOUND PROCEDURE TRAY— 510(k) K802666

Substantially Equivalent

Aptek , Ltd.

FDA 510(k) clearance K802666 for APTEK ULTRASOUND PROCEDURE TRAY, Substantially Equivalent on 1980-11-26. Applicant: Aptek , Ltd.. Device class: 1.

Clearance details

Applicant: Aptek , Ltd.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1980-10-28
Decision date: 1980-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.