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FDA 510(k)

LIFEBED PATIENT VIGILANCE SYSTEM

K-Number: K082366 · 2008-09-26

ApplicantHoana Medical, Inc.
Decision Date2008-09-26
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFEBED 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 2008-09-26 under 510(k) number K082366. 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 LIFEBED PATIENT VIGILANCE SYSTEM?

LIFEBED PATIENT VIGILANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is Hoana Medical, Inc.. The 510(k) number is K082366.

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

LIFEBED PATIENT VIGILANCE SYSTEM received FDA 510(k) clearance on 2008-09-26, under 510(k) number K082366.

Who is the listed applicant for LIFEBED 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 LIFEBED PATIENT VIGILANCE SYSTEM?

The FDA product code for LIFEBED 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 SYSTEMK092037LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEMK083534LIFEBED NETWORK 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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