AXISONIC II— 510(k) K810697

Substantially Equivalent

Teknar, Inc.

FDA 510(k) clearance K810697 for AXISONIC II, Substantially Equivalent on 1981-07-13. Applicant: Teknar, Inc.. Device class: 2.

Clearance details

Applicant: Teknar, Inc.
Product code: Code HDR
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1981-03-16
Decision date: 1981-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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