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FDA 510(k)

PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION

K-Number: K930494 · 1994-04-26

ApplicantElan Medical Technologies, Ltd.
Decision Date1994-04-26
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Elan Medical Technologies, Ltd.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K930494. 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 PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION?

PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Elan Medical Technologies, Ltd.. The 510(k) number is K930494.

When did PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION receive FDA 510(k) clearance?

PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION received FDA 510(k) clearance on 1994-04-26, under 510(k) number K930494.

Who is the listed applicant for PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION?

The FDA 510(k) record lists Elan Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION?

The FDA product code for PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION is FRN.

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Other records listing Elan Medical Technologies, Ltd. 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.

K930495PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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