Cleared Traditional

Freespira

K180173 · Palo Alto Health Sciences, Inc. · Neurology
Aug 2018
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K180173 is an FDA 510(k) clearance for the Freespira, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Palo Alto Health Sciences, Inc. (Kirkland, US). The FDA issued a Cleared decision on August 23, 2018, 213 days after receiving the submission on January 22, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K180173 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2018
Decision Date August 23, 2018
Days to Decision 213 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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