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FDA 510(k)

AMIGO INSULIN PUMP

K-Number: K071613 · 2007-12-14

ApplicantNipro Diabetes Systems, Inc.
Decision Date2007-12-14
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMIGO INSULIN PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Diabetes Systems, Inc.. It received FDA 510(k) clearance on 2007-12-14 under 510(k) number K071613. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIGO INSULIN PUMP?

AMIGO INSULIN PUMP is a medical device that received FDA 510(k) clearance on 2007-12-14. The listed applicant is Nipro Diabetes Systems, Inc.. The 510(k) number is K071613.

When did AMIGO INSULIN PUMP receive FDA 510(k) clearance?

AMIGO INSULIN PUMP received FDA 510(k) clearance on 2007-12-14, under 510(k) number K071613.

Who is the listed applicant for AMIGO INSULIN PUMP?

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

What is the FDA product code for AMIGO INSULIN PUMP?

The FDA product code for AMIGO INSULIN PUMP is LZG.

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 Nipro Diabetes Systems, 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.

K050312AMIGO INSULIN PUMPK014114GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXXK013309GLUCOPRO EVO INFUSION PUMPK011120GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES

Related Devices (Code: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

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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