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FDA 510(k)

PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT

K-Number: K010824 · 2001-06-05

ApplicantScience Incorporated
Decision Date2001-06-05
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Science Incorporated. It received FDA 510(k) clearance on 2001-06-05 under 510(k) number K010824. 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 PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT?

PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT is a medical device that received FDA 510(k) clearance on 2001-06-05. The listed applicant is Science Incorporated. The 510(k) number is K010824.

When did PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT receive FDA 510(k) clearance?

PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT received FDA 510(k) clearance on 2001-06-05, under 510(k) number K010824.

Who is the listed applicant for PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT?

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

What is the FDA product code for PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT?

The FDA product code for PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT 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 Science Incorporated 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.

K020881MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KITK990208PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORTK971362PERSONAL INFUSOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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