ExSpiron 1Xi

FDA 510(k) K173181 · Respiratory Motion, Inc.

Substantially Equivalent

510(k) numberK173181

Submission

Device name
ExSpiron 1Xi
Applicant
Respiratory Motion, Inc.
Waltham, MA, US
Received
September 29, 2017
Decision date
March 16, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZK – Spirometer, Monitoring (W/Wo Alarm)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1850
Specialty
Anesthesiology

Other 510(k)s with product code BZK

510(k)DeviceApplicantDecision
K192584BEACON Caresystem Model 00002144BZK · Traditional Mermaid Care A/S12/18/2019SE
K192595ExSpiron 2XiBZK · Special Respiratory Motion12/17/2019SE
K180788Gas Module 3BZK · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.10/24/2018SE
K162131ExSpiron 1XiBZK · Traditional Respiratory Motion, Inc.05/09/2017SE
K130170Exspiron 1XIBZK · Special Respiratory Motion, Inc.05/29/2013SE
K120087ExspironBZK · Traditional Respiratory Motion, Inc.09/26/2012SE
K103578Philips NM3 Respiratory Monitor with VentassistBZK · Traditional Respironics Novametrix, LLC06/02/2011SE
K091853Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014BZK · Traditional Nspire Health, Inc.09/21/2009SE
K092217Mercury VCO2BZK · Special Respironics Novametrix, Inc.08/21/2009SE
K091459Philips NM3 Monitor, Model 7900BZK · Special Respironics Novametrix, LLC07/28/2009SE

More from Respironics Novametrix, LLC

510(k)DeviceDecision
K192595ExSpiron 2XiBZK · Special 12/17/2019SE
K162131ExSpiron 1XiBZK · Traditional 05/09/2017SE
K130170Exspiron 1XIBZK · Special 05/29/2013SE
K120087ExspironBZK · Traditional 09/26/2012SE

Questions and answers

When was ExSpiron 1Xi cleared by the FDA?

ExSpiron 1Xi (K173181) received a 510(k) decision of Substantially Equivalent on March 16, 2018, 168 days after the submission was received.

What is the product code of K173181?

The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.