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FDA 510(k)

AUTOFUSER

K-Number: K060258 · 2006-05-30

ApplicantAce Medical Us, LLC
Decision Date2006-05-30
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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 2006-05-30 under 510(k) number K060258. 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 AUTOFUSER?

AUTOFUSER is a medical device that received FDA 510(k) clearance on 2006-05-30. The listed applicant is Ace Medical Us, LLC. The 510(k) number is K060258.

When did AUTOFUSER receive FDA 510(k) clearance?

AUTOFUSER received FDA 510(k) clearance on 2006-05-30, under 510(k) number K060258.

Who is the listed applicant for 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 AUTOFUSER?

The FDA product code for 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.

K090300MODIFICATION TO AUTOFUSER

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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