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FDA 510(k)

ICU MEDICAL SINGLE-USE SYRINGE

K-Number: K070856 · 2007-10-05

ApplicantIcu Medical, Inc.
Decision Date2007-10-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ICU MEDICAL SINGLE-USE SYRINGE 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 2007-10-05 under 510(k) number K070856. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICU MEDICAL SINGLE-USE SYRINGE?

ICU MEDICAL SINGLE-USE SYRINGE is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Icu Medical, Inc.. The 510(k) number is K070856.

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

ICU MEDICAL SINGLE-USE SYRINGE received FDA 510(k) clearance on 2007-10-05, under 510(k) number K070856.

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

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 SINGLE-USE SYRINGE?

The FDA product code for ICU MEDICAL SINGLE-USE SYRINGE is FMF.

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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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