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FDA 510(k)

MELODIE INFUSION PUMP

K-Number: K980378 · 1998-12-09

Decision Date1998-12-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MELODIE INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Compagnie DE Developpement Aguettant. It received FDA 510(k) clearance on 1998-12-09 under 510(k) number K980378. 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 MELODIE INFUSION PUMP?

MELODIE INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1998-12-09. The listed applicant is Compagnie DE Developpement Aguettant. The 510(k) number is K980378.

When did MELODIE INFUSION PUMP receive FDA 510(k) clearance?

MELODIE INFUSION PUMP received FDA 510(k) clearance on 1998-12-09, under 510(k) number K980378.

Who is the listed applicant for MELODIE INFUSION PUMP?

The FDA 510(k) record lists Compagnie DE Developpement Aguettant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MELODIE INFUSION PUMP?

The FDA product code for MELODIE INFUSION PUMP 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.

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

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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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