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FDA 510(k)

EXSPIRON

K-Number: K120087 · 2012-09-26

ApplicantRespiratory Motion, Inc.
Decision Date2012-09-26
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EXSPIRON 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 2012-09-26 under 510(k) number K120087. 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?

EXSPIRON is a medical device that received FDA 510(k) clearance on 2012-09-26. The listed applicant is Respiratory Motion, Inc.. The 510(k) number is K120087.

When did EXSPIRON receive FDA 510(k) clearance?

EXSPIRON received FDA 510(k) clearance on 2012-09-26, under 510(k) number K120087.

Who is the listed applicant for EXSPIRON?

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?

The FDA product code for EXSPIRON is BZK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K173181ExSpiron 1XiK162131ExSpiron 1XiK130170EXSPIRON 1XI

Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas 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.

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