Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE

K-Number: K043604 · 2005-04-29

ApplicantVivometrics, Inc.
Decision Date2005-04-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Vivometrics, Inc.. It received FDA 510(k) clearance on 2005-04-29 under 510(k) number K043604. 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 LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE?

LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE is a medical device that received FDA 510(k) clearance on 2005-04-29. The listed applicant is Vivometrics, Inc.. The 510(k) number is K043604.

When did LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE receive FDA 510(k) clearance?

LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE received FDA 510(k) clearance on 2005-04-29, under 510(k) number K043604.

Who is the listed applicant for LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE?

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

What is the FDA product code for LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE?

The FDA product code for LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE is DQK.

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 Vivometrics, 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.

K031550REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWAREK011903LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

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

View on FDA Database →

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

↑