Cleared Special

EXSPIRON 1XI

K130170 · Respiratory Motion, Inc. · Anesthesiology
May 2013
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K130170 is an FDA 510(k) clearance for the EXSPIRON 1XI, a Spirometer, Monitoring (w/wo Alarm) (Class II — Special Controls, product code BZK), submitted by Respiratory Motion, Inc. (Waltham, US). The FDA issued a Cleared decision on May 29, 2013, 125 days after receiving the submission on January 24, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1850.

Submission Details

510(k) Number K130170 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2013
Decision Date May 29, 2013
Days to Decision 125 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZK — Spirometer, Monitoring (w/wo Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1850