Cleared Traditional

SONDREX P.A.L. SYSTEM

K010388 · Ohmeda Medical · Neurology
Dec 2001
Decision
306d
Days
Class 2
Risk

About This 510(k) Submission

K010388 is an FDA 510(k) clearance for the SONDREX P.A.L. SYSTEM, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on December 11, 2001, 306 days after receiving the submission on February 8, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K010388 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2001
Decision Date December 11, 2001
Days to Decision 306 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050