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FDA 510(k)

MODIFICATION TO AUTOFUSER

K-Number: K090300 · 2009-04-30

ApplicantAce Medical Us, LLC
Decision Date2009-04-30
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AUTOFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Us, LLC. It received FDA 510(k) clearance on 2009-04-30 under 510(k) number K090300. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO AUTOFUSER?

MODIFICATION TO AUTOFUSER is a medical device that received FDA 510(k) clearance on 2009-04-30. The listed applicant is Ace Medical Us, LLC. The 510(k) number is K090300.

When did MODIFICATION TO AUTOFUSER receive FDA 510(k) clearance?

MODIFICATION TO AUTOFUSER received FDA 510(k) clearance on 2009-04-30, under 510(k) number K090300.

Who is the listed applicant for MODIFICATION TO AUTOFUSER?

The FDA 510(k) record lists Ace Medical Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO AUTOFUSER?

The FDA product code for MODIFICATION TO AUTOFUSER is MEB.

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 Ace Medical Us, LLC 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.

K060258AUTOFUSER

Related Devices (Code: MEB)

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.

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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