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FDA 510(k)

ALPHA INFUSION PUMP, MODEL A200, A450

K-Number: K071532 · 2008-02-19

ApplicantAdvanced Infusion, Inc.
Decision Date2008-02-19
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALPHA INFUSION PUMP, MODEL A200, A450 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Infusion, Inc.. It received FDA 510(k) clearance on 2008-02-19 under 510(k) number K071532. 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 ALPHA INFUSION PUMP, MODEL A200, A450?

ALPHA INFUSION PUMP, MODEL A200, A450 is a medical device that received FDA 510(k) clearance on 2008-02-19. The listed applicant is Advanced Infusion, Inc.. The 510(k) number is K071532.

When did ALPHA INFUSION PUMP, MODEL A200, A450 receive FDA 510(k) clearance?

ALPHA INFUSION PUMP, MODEL A200, A450 received FDA 510(k) clearance on 2008-02-19, under 510(k) number K071532.

Who is the listed applicant for ALPHA INFUSION PUMP, MODEL A200, A450?

The FDA 510(k) record lists Advanced Infusion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA INFUSION PUMP, MODEL A200, A450?

The FDA product code for ALPHA INFUSION PUMP, MODEL A200, A450 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Advanced Infusion, 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.

K061661STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20K061356POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6K042246MULTI-DRIP INFUSION CATHETERK021964ALPHA INFUSION PUMP AND CATHETERSK992551ALPHA INFUSION PUMP

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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