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FDA 510(k)

DISETRONIC PANOMAT PUMP

K-Number: K915566 · 1992-08-07

ApplicantDisetronic Medical Systems
Decision Date1992-08-07
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISETRONIC PANOMAT 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 1992-08-07 under 510(k) number K915566. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISETRONIC PANOMAT PUMP?

DISETRONIC PANOMAT PUMP is a medical device that received FDA 510(k) clearance on 1992-08-07. The listed applicant is Disetronic Medical Systems. The 510(k) number is K915566.

When did DISETRONIC PANOMAT PUMP receive FDA 510(k) clearance?

DISETRONIC PANOMAT PUMP received FDA 510(k) clearance on 1992-08-07, under 510(k) number K915566.

Who is the listed applicant for DISETRONIC PANOMAT 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 PANOMAT PUMP?

The FDA product code for DISETRONIC PANOMAT PUMP is FRN.

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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: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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