GRAYLINE IMAGING SYSTEM— 510(k) K811520

Substantially Equivalent

Sonics Research Corp.

FDA 510(k) clearance K811520 for GRAYLINE IMAGING SYSTEM, Substantially Equivalent on 1981-07-02. Applicant: Sonics Research Corp.. Device class: 2.

Clearance details

Applicant: Sonics Research Corp.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1981-05-29
Decision date: 1981-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.