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FDA 510(k)

DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP

K-Number: K973044 · 1997-09-15

ApplicantDisetronic Medical Systems
Decision Date1997-09-15
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP 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 1997-09-15 under 510(k) number K973044. 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 DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP?

DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1997-09-15. The listed applicant is Disetronic Medical Systems. The 510(k) number is K973044.

When did DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP receive FDA 510(k) clearance?

DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP received FDA 510(k) clearance on 1997-09-15, under 510(k) number K973044.

Who is the listed applicant for DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP?

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 H-TRON PLUS V 100 INSULIN INFUSION PUMP?

The FDA product code for DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP is LZG.

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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 NEEDLEK993666DISETRONIC PEN P100K991376DAHEDI INSULIN INFUSION PUMPK990259DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

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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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