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FDA 510(k)

LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM

K-Number: K092037 · 2009-10-02

ApplicantHoana Medical, Inc.
Decision Date2009-10-02
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hoana Medical, Inc.. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K092037. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM?

LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is Hoana Medical, Inc.. The 510(k) number is K092037.

When did LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM receive FDA 510(k) clearance?

LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM received FDA 510(k) clearance on 2009-10-02, under 510(k) number K092037.

Who is the listed applicant for LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM?

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

What is the FDA product code for LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM?

The FDA product code for LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM is DRT.

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 Hoana Medical, 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.

K100745LIFEBED NETWORK PATIENT VIGILANCE SYSTEMK083534LIFEBED NETWORK PATIENT VIGILANCE SYSTEMK082366LIFEBED PATIENT VIGILANCE SYSTEMK052446LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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