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FDA 510(k)

Modular Medical MODD1 Insulin Delivery System

K-Number: K240158 · 2024-09-04

ApplicantModular Medical, Inc.
Decision Date2024-09-04
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Modular Medical MODD1 Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Modular Medical, Inc.. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K240158. 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 Modular Medical MODD1 Insulin Delivery System?

Modular Medical MODD1 Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Modular Medical, Inc.. The 510(k) number is K240158.

When did Modular Medical MODD1 Insulin Delivery System receive FDA 510(k) clearance?

Modular Medical MODD1 Insulin Delivery System received FDA 510(k) clearance on 2024-09-04, under 510(k) number K240158.

Who is the listed applicant for Modular Medical MODD1 Insulin Delivery System?

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

What is the FDA product code for Modular Medical MODD1 Insulin Delivery System?

The FDA product code for Modular Medical MODD1 Insulin Delivery System is LZG.

Other records listing Modular Medical, 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.

K253534Pivot Insulin Delivery System

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.

K253534Pivot Insulin Delivery SystemModular MedicalK241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet CorporationK192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation

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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