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FDA 510(k)

GENESIS OTC MONITOR

K-Number: K061087 · 2006-06-09

ApplicantHoneywell Hommed, LLC
Decision Date2006-06-09
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GENESIS OTC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell Hommed, LLC. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K061087. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS OTC MONITOR?

GENESIS OTC MONITOR is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is Honeywell Hommed, LLC. The 510(k) number is K061087.

When did GENESIS OTC MONITOR receive FDA 510(k) clearance?

GENESIS OTC MONITOR received FDA 510(k) clearance on 2006-06-09, under 510(k) number K061087.

Who is the listed applicant for GENESIS OTC MONITOR?

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

What is the FDA product code for GENESIS OTC MONITOR?

The FDA product code for GENESIS OTC MONITOR is DRG.

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Other records listing Honeywell Hommed, LLC 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.

K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStreamK112858GENESIS TOUCH SYSTEMK101242GENESIS DM MODEL: 6053000A1K072272HONEYWELL HOMMED CENTRAL STATION 4.0K061088SENTRY OTC MONITORK053453HOMMED CENTRAL STATION, VERSION 3.5

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Related Devices (Code: DRG)

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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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.

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