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FDA 510(k)

MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300

K-Number: K031741 · 2004-02-09

ApplicantAlaris Medical Systems, Inc.
Decision Date2004-02-09
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 is the device name listed in this FDA 510(k) record. The listed applicant is Alaris Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-02-09 under 510(k) number K031741. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300?

MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 is a medical device that received FDA 510(k) clearance on 2004-02-09. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K031741.

When did MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 receive FDA 510(k) clearance?

MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 received FDA 510(k) clearance on 2004-02-09, under 510(k) number K031741.

Who is the listed applicant for MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300?

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

What is the FDA product code for MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300?

The FDA product code for MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 is CCK.

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Other records listing Alaris Medical Systems, Inc. as applicant

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Related Devices (Code: CCK)

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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