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FDA 510(k)

Modus IR

K-Number: K231986 · 2024-03-25

ApplicantSynaptive Medical, Inc.
Decision Date2024-03-25
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Modus IR is a medical device manufactured by Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2024-03-25 under approval number K231986. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modus IR?

Modus IR is a medical device that received FDA 510(k) clearance on 2024-03-25. It is manufactured by Synaptive Medical, Inc.. The 510(k) number is K231986.

When was Modus IR approved by the FDA?

Modus IR received FDA 510(k) clearance on 2024-03-25, under approval number K231986.

What company makes Modus IR?

Modus IR is manufactured by Synaptive Medical, Inc..

What is the FDA product code for Modus IR?

The FDA product code for Modus IR is IZI.

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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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