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FDA 510(k)

LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

K-Number: K011903 · 2002-04-12

ApplicantVivometrics, Inc.
Decision Date2002-04-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS 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 2002-04-12 under 510(k) number K011903. 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 SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE?

LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE is a medical device that received FDA 510(k) clearance on 2002-04-12. The listed applicant is Vivometrics, Inc.. The 510(k) number is K011903.

When did LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE receive FDA 510(k) clearance?

LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE received FDA 510(k) clearance on 2002-04-12, under 510(k) number K011903.

Who is the listed applicant for LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS 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 SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE?

The FDA product code for LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS 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.

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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.

K043604LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWAREK031550REUSABLE MULTIPLE-PATIENT LIFESHIRT 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

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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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