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FDA 510(k)

ACCUFUSER; ACCUFUSER PLUS

K-Number: K003915 · 2001-02-15

ApplicantHelp Technologies
Decision Date2001-02-15
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCUFUSER; ACCUFUSER PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Help Technologies. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K003915. 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 ACCUFUSER; ACCUFUSER PLUS?

ACCUFUSER; ACCUFUSER PLUS is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Help Technologies. The 510(k) number is K003915.

When did ACCUFUSER; ACCUFUSER PLUS receive FDA 510(k) clearance?

ACCUFUSER; ACCUFUSER PLUS received FDA 510(k) clearance on 2001-02-15, under 510(k) number K003915.

Who is the listed applicant for ACCUFUSER; ACCUFUSER PLUS?

The FDA 510(k) record lists Help Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUFUSER; ACCUFUSER PLUS?

The FDA product code for ACCUFUSER; ACCUFUSER PLUS 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 Help Technologies 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.

K023973AUTOMED 3200 INFUSION PUMPK023863AUTOMED 3000 INFUSION PUMPK023491AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM

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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