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FDA 510(k)

iLet® Dosing Decision Software

K-Number: K220916 · 2023-05-19

ApplicantBeta Bionics, Inc.
Decision Date2023-05-19
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iLet® Dosing Decision Software is the device name listed in this FDA 510(k) record. The listed applicant is Beta Bionics, Inc.. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K220916. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iLet® Dosing Decision Software?

iLet® Dosing Decision Software is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Beta Bionics, Inc.. The 510(k) number is K220916.

When did iLet® Dosing Decision Software receive FDA 510(k) clearance?

iLet® Dosing Decision Software received FDA 510(k) clearance on 2023-05-19, under 510(k) number K220916.

Who is the listed applicant for iLet® Dosing Decision Software?

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

What is the FDA product code for iLet® Dosing Decision Software?

The FDA product code for iLet® Dosing Decision Software is QJI.

Other records listing Beta Bionics, 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.

K253976iLet ACE PumpK252770iLet ACE PumpK232224iLet® Dosing Decision SoftwareK231485iLet® ACE PumpK223846iLet® ACE Pump

Related Devices (Code: QJI)

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 TechnologyMedtronic MiniMedK261461Omnipod 6 algorithmInsulet CorporationK260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MinimedK253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.K251152DBLG2Diabeloop

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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