SleepCheckRx
K-Number: K213360 · 2022-07-05
ApplicantResapp Health
Decision Date2022-07-05
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
SleepCheckRx is a medical device manufactured by Resapp Health. It received FDA 510(k) clearance on 2022-07-05 under approval number K213360. 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 SleepCheckRx?
SleepCheckRx is a medical device that received FDA 510(k) clearance on 2022-07-05. It is manufactured by Resapp Health. The 510(k) number is K213360.
When was SleepCheckRx approved by the FDA?
SleepCheckRx received FDA 510(k) clearance on 2022-07-05, under approval number K213360.
What company makes SleepCheckRx?
SleepCheckRx is manufactured by Resapp Health.
What is the FDA product code for SleepCheckRx?
The FDA product code for SleepCheckRx 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.