ASC 4080 SYSTEM— 510(k) K843634

Substantially Equivalent

Atlantis Scientific Corp.

FDA 510(k) clearance K843634 for ASC 4080 SYSTEM, Substantially Equivalent on 1984-11-08. Applicant: Atlantis Scientific Corp.. Device class: 1.

Clearance details

Applicant: Atlantis Scientific Corp.
Product code: Code IKE
Device class: Class 1
Regulation: 21 CFR 890.1615
Advisory panel: Physical Medicine
Date received: 1984-09-17
Decision date: 1984-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.