MAXI-SCOPE OR ULTRA-SCOPE— 510(k) K912128

Substantially Equivalent

Seiichi Mfg., Inc.

FDA 510(k) clearance K912128 for MAXI-SCOPE OR ULTRA-SCOPE, Substantially Equivalent on 1991-06-28. Applicant: Seiichi Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Seiichi Mfg., Inc.
Product code: Code LDE
Device class: Class 1
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 1991-05-14
Decision date: 1991-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, KY, 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.