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FDA 510(k)

ZIEN IO Intraosseous Access System

K-Number: K240915 · 2024-07-02

ApplicantZien Medical Technologies, Inc.
Decision Date2024-07-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZIEN IO Intraosseous Access System is the device name listed in this FDA 510(k) record. The listed applicant is Zien Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K240915. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIEN IO Intraosseous Access System?

ZIEN IO Intraosseous Access System is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Zien Medical Technologies, Inc.. The 510(k) number is K240915.

When did ZIEN IO Intraosseous Access System receive FDA 510(k) clearance?

ZIEN IO Intraosseous Access System received FDA 510(k) clearance on 2024-07-02, under 510(k) number K240915.

Who is the listed applicant for ZIEN IO Intraosseous Access System?

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

What is the FDA product code for ZIEN IO Intraosseous Access System?

The FDA product code for ZIEN IO Intraosseous Access System is FMI.

Other records listing Zien Medical Technologies, 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.

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Official Source

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