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FDA 510(k)

APNEA RISK EVALUATION SYSTEM (ARES)

K-Number: K110705 · 2011-04-14

ApplicantAdvanced Brain Monitoring, Inc.
Decision Date2011-04-14
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNEA RISK EVALUATION SYSTEM (ARES) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Brain Monitoring, Inc.. It received FDA 510(k) clearance on 2011-04-14 under 510(k) number K110705. 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)?

APNEA RISK EVALUATION SYSTEM (ARES) is a medical device that received FDA 510(k) clearance on 2011-04-14. The listed applicant is Advanced Brain Monitoring, Inc.. The 510(k) number is K110705.

When did APNEA RISK EVALUATION SYSTEM (ARES) receive FDA 510(k) clearance?

APNEA RISK EVALUATION SYSTEM (ARES) received FDA 510(k) clearance on 2011-04-14, under 510(k) number K110705.

Who is the listed applicant for APNEA RISK EVALUATION SYSTEM (ARES)?

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

What is the FDA product code for APNEA RISK EVALUATION SYSTEM (ARES)?

The FDA product code for APNEA RISK EVALUATION SYSTEM (ARES) 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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