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FDA 510(k)

INFU.DISK

K-Number: K904619 · 1991-11-05

ApplicantElectrochemical Drug Delivery, Inc.
Decision Date1991-11-05
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFU.DISK is the device name listed in this FDA 510(k) record. The listed applicant is Electrochemical Drug Delivery, Inc.. It received FDA 510(k) clearance on 1991-11-05 under 510(k) number K904619. 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 INFU.DISK?

INFU.DISK is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Electrochemical Drug Delivery, Inc.. The 510(k) number is K904619.

When did INFU.DISK receive FDA 510(k) clearance?

INFU.DISK received FDA 510(k) clearance on 1991-11-05, under 510(k) number K904619.

Who is the listed applicant for INFU.DISK?

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

What is the FDA product code for INFU.DISK?

The FDA product code for INFU.DISK is FRN.

Other records listing Electrochemical Drug Delivery, 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.

K920013UNI-DOSE SYRINGE PUMP

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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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