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FDA 510(k)

RESPITRAK

K-Number: K884959 · 1989-06-08

ApplicantNon-Invasive Monitoring Systems, Inc.
Decision Date1989-06-08
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPITRAK is the device name listed in this FDA 510(k) record. The listed applicant is Non-Invasive Monitoring Systems, Inc.. It received FDA 510(k) clearance on 1989-06-08 under 510(k) number K884959. 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 RESPITRAK?

RESPITRAK is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Non-Invasive Monitoring Systems, Inc.. The 510(k) number is K884959.

When did RESPITRAK receive FDA 510(k) clearance?

RESPITRAK received FDA 510(k) clearance on 1989-06-08, under 510(k) number K884959.

Who is the listed applicant for RESPITRAK?

The FDA 510(k) record lists Non-Invasive Monitoring Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPITRAK?

The FDA product code for RESPITRAK 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 Non-Invasive Monitoring Systems, 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.

K012020RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PCK001369RESPIEVENTS, VERSION 4.2K942852RESPITRACE PTK942771RESPIEVENTSK903011RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL

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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