FDA 510(k)

ExSpiron 2Xi

K-Number: K192595 · 2019-12-17

Decision Date2019-12-17

Product CodeBZK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ExSpiron 2Xi is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Motion. It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K192595. 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 2Xi?

ExSpiron 2Xi is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Respiratory Motion. The 510(k) number is K192595.

When did ExSpiron 2Xi receive FDA 510(k) clearance?

ExSpiron 2Xi received FDA 510(k) clearance on 2019-12-17, under 510(k) number K192595.

Who is the listed applicant for ExSpiron 2Xi?

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

What is the FDA product code for ExSpiron 2Xi?

The FDA product code for ExSpiron 2Xi is BZK.

Other records listing Respiratory Motion 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.

K173181ExSpiron 1Xi K162131ExSpiron 1Xi

Related Devices (Code: BZK)

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