Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SleepCheckRx

K-Number: K213360 · 2022-07-05

ApplicantResapp Health
Decision Date2022-07-05
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SleepCheckRx is the device name listed in this FDA 510(k) record. The listed applicant is Resapp Health. It received FDA 510(k) clearance on 2022-07-05 under 510(k) 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. The listed applicant is Resapp Health. The 510(k) number is K213360.

When did SleepCheckRx receive FDA 510(k) clearance?

SleepCheckRx received FDA 510(k) clearance on 2022-07-05, under 510(k) number K213360.

Who is the listed applicant for SleepCheckRx?

The FDA 510(k) record lists Resapp Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SleepCheckRx?

The FDA product code for SleepCheckRx is MNR.

Related Devices (Code: MNR)

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.

K254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley MedicalK250882SANSA HSATHuxley Medical

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.

↑