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FDA 510(k)

Apnea Risk Evaluation System (ARES), Model 620

K-Number: K160499 · 2017-04-24

ApplicantWatermark Medical
Decision Date2017-04-24
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Apnea Risk Evaluation System (ARES), Model 620 is a medical device manufactured by Watermark Medical. It received FDA 510(k) clearance on 2017-04-24 under approval number K160499. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apnea Risk Evaluation System (ARES), Model 620?

Apnea Risk Evaluation System (ARES), Model 620 is a medical device that received FDA 510(k) clearance on 2017-04-24. It is manufactured by Watermark Medical. The 510(k) number is K160499.

When was Apnea Risk Evaluation System (ARES), Model 620 approved by the FDA?

Apnea Risk Evaluation System (ARES), Model 620 received FDA 510(k) clearance on 2017-04-24, under approval number K160499.

What company makes Apnea Risk Evaluation System (ARES), Model 620?

Apnea Risk Evaluation System (ARES), Model 620 is manufactured by Watermark Medical.

What is the FDA product code for Apnea Risk Evaluation System (ARES), Model 620?

The FDA product code for Apnea Risk Evaluation System (ARES), Model 620 is MNR.

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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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