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FDA 510(k)

MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600

K-Number: K041241 · 2004-07-06

Decision Date2004-07-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 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 2004-07-06 under 510(k) number K041241. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600?

MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 is a medical device that received FDA 510(k) clearance on 2004-07-06. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K041241.

When did MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 receive FDA 510(k) clearance?

MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 received FDA 510(k) clearance on 2004-07-06, under 510(k) number K041241.

Who is the listed applicant for MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600?

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 SYSTEM WITH BAR CODE MODULE, MODEL 8600?

The FDA product code for MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 is FRN.

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.

Other records listing Alaris Medical Systems, 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: FRN)

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.

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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