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FDA 510(k)

Altris IMS

K-Number: K232088 · 2023-07-31

ApplicantAltris, Inc.
Decision Date2023-07-31
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Altris IMS is the device name listed in this FDA 510(k) record. The listed applicant is Altris, Inc.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K232088. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altris IMS?

Altris IMS is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Altris, Inc.. The 510(k) number is K232088.

When did Altris IMS receive FDA 510(k) clearance?

Altris IMS received FDA 510(k) clearance on 2023-07-31, under 510(k) number K232088.

Who is the listed applicant for Altris IMS?

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

What is the FDA product code for Altris IMS?

The FDA product code for Altris IMS is NFJ.

Related Devices (Code: NFJ)

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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