FDA 510(k)

ExSpiron 1Xi

K-Number: K173181 · 2018-03-16

Decision Date2018-03-16

Product CodeBZK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ExSpiron 1Xi is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Motion, Inc.. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K173181. 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 2018-03-16. The listed applicant is Respiratory Motion, Inc.. The 510(k) number is K173181.

When did ExSpiron 1Xi receive FDA 510(k) clearance?

ExSpiron 1Xi received FDA 510(k) clearance on 2018-03-16, under 510(k) number K173181.

Who is the listed applicant for ExSpiron 1Xi?

The FDA 510(k) record lists Respiratory Motion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ExSpiron 1Xi?

The FDA product code for ExSpiron 1Xi is BZK.

Other records listing Respiratory Motion, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192595ExSpiron 2Xi K162131ExSpiron 1Xi

Related Devices (Code: BZK)

K192584BEACON Caresystem Model 00002144Mermaid Care A/S K192595ExSpiron 2XiRespiratory Motion K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K162131ExSpiron 1XiRespiratory Motion, Inc.

Official Source

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