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 the device name listed in this FDA 510(k) record. The listed applicant is Mdoloris Medical Systems Sas. It received FDA 510(k) clearance on 2016-02-23 under 510(k) 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. The listed applicant is Mdoloris Medical Systems Sas. The 510(k) number is K142969.

When did ANI Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for ANI Monitor?

The FDA 510(k) record lists Mdoloris Medical Systems Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANI Monitor?

The FDA product code for ANI Monitor is DPS.

Related Devices (Code: DPS)

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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial K243252ZBPro DiagnosticZbeats, Inc.

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.