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MNR — Ventilatory Effort Recorder Class II

FDA Device Classification

Classification Details

Product Code
MNR
Device Class
Class II
Regulation Number
868.2375
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K243092acurable limitedAcuPebble Ox (200)March 19, 2025
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K242290dormotech medicalDormoTech NLabJanuary 8, 2025
K242424cadwell industriesBluebird Single-Use Respiratory Effort BeltDecember 18, 2024
K231667withingsWithings Sleep RxSeptember 6, 2024
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K240285huxley medicalHuxley SANSA Home Sleep Apnea Test (1000-00)July 15, 2024
K240100snap diagnosticsSAM Model 9-10000June 4, 2024
K231355ensodataAuroraFebruary 9, 2024
K231546compumedics limitedSomfitNovember 30, 2023
K223573oneraOnera Sleep Test System (Onera STS)August 18, 2023
K221816wesperWesper LabMarch 9, 2023
K222579belun technology company limitedBelun Sleep System BLS-100February 23, 2023