Cleared Abbreviated

MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES

K071782 · Micromed S.P.A. · Neurology
Jan 2008
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K071782 is an FDA 510(k) clearance for the MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Micromed S.P.A. (Mogliano Veneto (Tv), IT). The FDA issued a Cleared decision on January 10, 2008, 192 days after receiving the submission on July 2, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K071782 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2007
Decision Date January 10, 2008
Days to Decision 192 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLV — Standard Polysomnograph With Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.