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FDA 510(k)

RESPIEVENTS, VERSION 4.2

K-Number: K001369 · 2000-07-26

ApplicantNon-Invasive Monitoring Systems, Inc.
Decision Date2000-07-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESPIEVENTS, VERSION 4.2 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 2000-07-26 under 510(k) number K001369. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIEVENTS, VERSION 4.2?

RESPIEVENTS, VERSION 4.2 is a medical device that received FDA 510(k) clearance on 2000-07-26. The listed applicant is Non-Invasive Monitoring Systems, Inc.. The 510(k) number is K001369.

When did RESPIEVENTS, VERSION 4.2 receive FDA 510(k) clearance?

RESPIEVENTS, VERSION 4.2 received FDA 510(k) clearance on 2000-07-26, under 510(k) number K001369.

Who is the listed applicant for RESPIEVENTS, VERSION 4.2?

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 RESPIEVENTS, VERSION 4.2?

The FDA product code for RESPIEVENTS, VERSION 4.2 is DQK.

Related Clinical Trials

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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 PCK942852RESPITRACE PTK942771RESPIEVENTSK903011RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRALK884959RESPITRAK

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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