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FDA 510(k)

ANI Monitor

K-Number: K142969 · 2016-02-23

Decision Date2016-02-23
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANI Monitor is a medical device manufactured by Mdoloris Medical Systems Sas. It received FDA 510(k) clearance on 2016-02-23 under approval number K142969. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANI Monitor?

ANI Monitor is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by Mdoloris Medical Systems Sas. The 510(k) number is K142969.

When was ANI Monitor approved by the FDA?

ANI Monitor received FDA 510(k) clearance on 2016-02-23, under approval number K142969.

What company makes ANI Monitor?

ANI Monitor is manufactured by Mdoloris Medical Systems Sas.

What is the FDA product code for ANI Monitor?

The FDA product code for ANI Monitor is DPS.

Related Devices (Code: DPS)

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.