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FDA 510(k)

MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311

K-Number: K993012 · 1999-11-15

ApplicantMedtronic Minimed
Decision Date1999-11-15
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 1999-11-15 under 510(k) number K993012. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311?

MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 is a medical device that received FDA 510(k) clearance on 1999-11-15. The listed applicant is Medtronic Minimed. The 510(k) number is K993012.

When did MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 receive FDA 510(k) clearance?

MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 received FDA 510(k) clearance on 1999-11-15, under 510(k) number K993012.

Who is the listed applicant for MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311?

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

What is the FDA product code for MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311?

The FDA product code for MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 is LZG.

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Other records listing Medtronic Minimed 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.

K261962SmartGuard Technology; Predictive Low Glucose TechnologyK253701SmartGuard Technology; Predictive Low Glucose TechnologyK253512MiniMed Go AppK242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))K241622Extended Reservoir; MiniMed ReservoirK160860MiniMed Quick-serter

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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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