SANDMAN— 510(k) K934599

Substantially Equivalent

Melville Software , Ltd.

FDA 510(k) clearance K934599 for SANDMAN, Substantially Equivalent on 1994-01-27. Applicant: Melville Software , Ltd.. Device class: 2.

Clearance details

Applicant: Melville Software , Ltd.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1993-09-24
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, Ontario, CA

Download summary PDF View on FDA.gov ↗

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