Cleared Traditional

K162131 - ExSpiron 1Xi
(FDA 510(k) Clearance)

K162131 · Respiratory Motion, Inc. · Anesthesiology
May 2017
Decision
281d
Days
Class 2
Risk

K162131 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 9, 2017, 281 days after receiving the submission on August 1, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1850.

Submission Details

510(k) Number K162131 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2016
Decision Date May 09, 2017
Days to Decision 281 days
Submission Type Traditional
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