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FDA 510(k)

SAM IO Intraosseous Access System

K-Number: K191488 · 2019-11-21

ApplicantSam® Medical Products, Inc.
Decision Date2019-11-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAM IO Intraosseous Access System is the device name listed in this FDA 510(k) record. The listed applicant is Sam® Medical Products, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K191488. 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 SAM IO Intraosseous Access System?

SAM IO Intraosseous Access System is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Sam® Medical Products, Inc.. The 510(k) number is K191488.

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

SAM IO Intraosseous Access System received FDA 510(k) clearance on 2019-11-21, under 510(k) number K191488.

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

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

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

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

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Related Devices (Code: FMI)

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

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