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FDA 510(k)

INFUSION DYNAMICS POWER INFUSER MODEL M100B

K-Number: K992044 · 1999-09-08

ApplicantInfusion Dynamics, Inc.
Decision Date1999-09-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION DYNAMICS POWER INFUSER MODEL M100B 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 1999-09-08 under 510(k) number K992044. 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 POWER INFUSER MODEL M100B?

INFUSION DYNAMICS POWER INFUSER MODEL M100B is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Infusion Dynamics, Inc.. The 510(k) number is K992044.

When did INFUSION DYNAMICS POWER INFUSER MODEL M100B receive FDA 510(k) clearance?

INFUSION DYNAMICS POWER INFUSER MODEL M100B received FDA 510(k) clearance on 1999-09-08, under 510(k) number K992044.

Who is the listed applicant for INFUSION DYNAMICS POWER INFUSER MODEL M100B?

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 POWER INFUSER MODEL M100B?

The FDA product code for INFUSION DYNAMICS POWER INFUSER MODEL M100B 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.

K030739INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGEK974074INFUSION 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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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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