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FDA 510(k)

ExSpiron 1Xi

K-Number: K162131 · 2017-05-09

ApplicantRespiratory Motion, Inc.
Decision Date2017-05-09
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ExSpiron 1Xi is a medical device manufactured by Respiratory Motion, Inc.. It received FDA 510(k) clearance on 2017-05-09 under approval number K162131. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExSpiron 1Xi?

ExSpiron 1Xi is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Respiratory Motion, Inc.. The 510(k) number is K162131.

When was ExSpiron 1Xi approved by the FDA?

ExSpiron 1Xi received FDA 510(k) clearance on 2017-05-09, under approval number K162131.

What company makes ExSpiron 1Xi?

ExSpiron 1Xi is manufactured by Respiratory Motion, Inc..

What is the FDA product code for ExSpiron 1Xi?

The FDA product code for ExSpiron 1Xi is BZK.

Other Devices by Respiratory Motion, Inc.

K173181ExSpiron 1Xi

Related Devices (Code: BZK)

K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd. K173181ExSpiron 1XiRespiratory Motion, Inc. K192584BEACON Caresystem Model 00002144Mermaid Care A/S K192595ExSpiron 2XiRespiratory Motion

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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