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FDA 510(k)

SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116

K-Number: K942181 · 1994-07-14

ApplicantMedtronic Minimed
Decision Date1994-07-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 1994-07-14 under 510(k) number K942181. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116?

SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 is a medical device that received FDA 510(k) clearance on 1994-07-14. The listed applicant is Medtronic Minimed. The 510(k) number is K942181.

When did SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 receive FDA 510(k) clearance?

SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 received FDA 510(k) clearance on 1994-07-14, under 510(k) number K942181.

Who is the listed applicant for SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116?

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 SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116?

The FDA product code for SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 is FPA.

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Other records listing Medtronic Minimed as applicant

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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: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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