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FDA 510(k)

WIRELESS MONITORING SYSTEM

K-Number: K110809 · 2011-07-05

ApplicantCarefusion 303, Inc.
Decision Date2011-07-05
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WIRELESS MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 303, Inc.. It received FDA 510(k) clearance on 2011-07-05 under 510(k) number K110809. 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 WIRELESS MONITORING SYSTEM?

WIRELESS MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-05. The listed applicant is Carefusion 303, Inc.. The 510(k) number is K110809.

When did WIRELESS MONITORING SYSTEM receive FDA 510(k) clearance?

WIRELESS MONITORING SYSTEM received FDA 510(k) clearance on 2011-07-05, under 510(k) number K110809.

Who is the listed applicant for WIRELESS MONITORING SYSTEM?

The FDA 510(k) record lists Carefusion 303, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIRELESS MONITORING SYSTEM?

The FDA product code for WIRELESS MONITORING SYSTEM is DRG.

Related Clinical Trials

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Other records listing Carefusion 303, 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.

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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

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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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