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FDA 510(k)

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES

K-Number: K082836 · 2009-02-25

ApplicantIcu Medical, Inc.
Decision Date2009-02-25
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2009-02-25 under 510(k) number K082836. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES?

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES is a medical device that received FDA 510(k) clearance on 2009-02-25. The listed applicant is Icu Medical, Inc.. The 510(k) number is K082836.

When did ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES receive FDA 510(k) clearance?

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES received FDA 510(k) clearance on 2009-02-25, under 510(k) number K082836.

Who is the listed applicant for ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES?

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

What is the FDA product code for ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES?

The FDA product code for ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES is FMG.

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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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