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FDA 510(k)

MTP E.V. INFUSION PUMP

K-Number: K842263 · 1984-07-25

ApplicantZiehm International, Inc.
Decision Date1984-07-25
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MTP E.V. INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm International, Inc.. It received FDA 510(k) clearance on 1984-07-25 under 510(k) number K842263. 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 MTP E.V. INFUSION PUMP?

MTP E.V. INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1984-07-25. The listed applicant is Ziehm International, Inc.. The 510(k) number is K842263.

When did MTP E.V. INFUSION PUMP receive FDA 510(k) clearance?

MTP E.V. INFUSION PUMP received FDA 510(k) clearance on 1984-07-25, under 510(k) number K842263.

Who is the listed applicant for MTP E.V. INFUSION PUMP?

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

What is the FDA product code for MTP E.V. INFUSION PUMP?

The FDA product code for MTP E.V. INFUSION PUMP is FRN.

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Other records listing Ziehm International, 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.

K011292ZIEHM VISIONK910455IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTORK902196MODIFIED STICK-GARD SAFETY NEEDLEK894021MOBILE X-RAY UNITK894041PUMP-JECT SYRINGE WITH LUER-LOCKK890620STICK-GARD SAFETY NEEDLE

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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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