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FDA 510(k)

MODEL IR 1200 INSULIN PUMP

K-Number: K032257 · 2003-10-16

ApplicantAnimas Corp.
Decision Date2003-10-16
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL IR 1200 INSULIN PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Animas Corp.. It received FDA 510(k) clearance on 2003-10-16 under 510(k) number K032257. 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 MODEL IR 1200 INSULIN PUMP?

MODEL IR 1200 INSULIN PUMP is a medical device that received FDA 510(k) clearance on 2003-10-16. The listed applicant is Animas Corp.. The 510(k) number is K032257.

When did MODEL IR 1200 INSULIN PUMP receive FDA 510(k) clearance?

MODEL IR 1200 INSULIN PUMP received FDA 510(k) clearance on 2003-10-16, under 510(k) number K032257.

Who is the listed applicant for MODEL IR 1200 INSULIN PUMP?

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

What is the FDA product code for MODEL IR 1200 INSULIN PUMP?

The FDA product code for MODEL IR 1200 INSULIN PUMP is LZG.

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Other records listing Animas Corp. 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.

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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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