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FDA 510(k)

SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET

K-Number: K061409 · 2006-06-16

ApplicantPrecise Medical Products, Ltd.
Decision Date2006-06-16
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Precise Medical Products, Ltd.. It received FDA 510(k) clearance on 2006-06-16 under 510(k) number K061409. 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 SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET?

SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET is a medical device that received FDA 510(k) clearance on 2006-06-16. The listed applicant is Precise Medical Products, Ltd.. The 510(k) number is K061409.

When did SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET receive FDA 510(k) clearance?

SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET received FDA 510(k) clearance on 2006-06-16, under 510(k) number K061409.

Who is the listed applicant for SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET?

The FDA 510(k) record lists Precise Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET?

The FDA product code for SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET is MEB.

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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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