Cleared Traditional

COMPUMEDICS SIESTA SYSTEM

K003175 · Compumedics Limited · Neurology
Dec 2000
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K003175 is an FDA 510(k) clearance for the COMPUMEDICS SIESTA SYSTEM, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Compumedics Limited (Minneapolis,, US). The FDA issued a Cleared decision on December 27, 2000, 78 days after receiving the submission on October 10, 2000. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K003175 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2000
Decision Date December 27, 2000
Days to Decision 78 days
Submission Type Traditional
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.