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FDA 510(k)

DISETRONIC PEN P100

K-Number: K993666 · 1999-11-22

ApplicantDisetronic Medical Systems
Decision Date1999-11-22
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISETRONIC PEN P100 is the device name listed in this FDA 510(k) record. The listed applicant is Disetronic Medical Systems. It received FDA 510(k) clearance on 1999-11-22 under 510(k) number K993666. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISETRONIC PEN P100?

DISETRONIC PEN P100 is a medical device that received FDA 510(k) clearance on 1999-11-22. The listed applicant is Disetronic Medical Systems. The 510(k) number is K993666.

When did DISETRONIC PEN P100 receive FDA 510(k) clearance?

DISETRONIC PEN P100 received FDA 510(k) clearance on 1999-11-22, under 510(k) number K993666.

Who is the listed applicant for DISETRONIC PEN P100?

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

What is the FDA product code for DISETRONIC PEN P100?

The FDA product code for DISETRONIC PEN P100 is FMF.

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Other records listing Disetronic Medical Systems 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.

K013782DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLEK994186DISETRONIC D-TRON INSULIN INFUSION PUMPK994197DISENTRONIC PENFINE INJECTION PEN NEEDLEK991376DAHEDI INSULIN INFUSION PUMPK990259DISETRONIC MULTIFUSE INFUSION PUMP SYSTEMK982966DISETRONIC PEN

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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