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FDA 510(k)

INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE

K-Number: K030739 · 2004-01-14

ApplicantInfusion Dynamics, Inc.
Decision Date2004-01-14
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Infusion Dynamics, Inc.. It received FDA 510(k) clearance on 2004-01-14 under 510(k) number K030739. 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 INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE?

INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE is a medical device that received FDA 510(k) clearance on 2004-01-14. The listed applicant is Infusion Dynamics, Inc.. The 510(k) number is K030739.

When did INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE receive FDA 510(k) clearance?

INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE received FDA 510(k) clearance on 2004-01-14, under 510(k) number K030739.

Who is the listed applicant for INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE?

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

What is the FDA product code for INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE?

The FDA product code for INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE 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.

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Other records listing Infusion Dynamics, 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.

K992044INFUSION DYNAMICS POWER INFUSER MODEL M100BK974074INFUSION DYNAMICS POWER INFUSER

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.

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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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