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510(k) K243220

Onera STS 2 (ONERA STS 2) by Onera B.V. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
October 7, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Onera B.V.

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  • K223573 — Onera Sleep Test System (Onera STS) (August 18, 2023)
  • K210593 — Onera Sleep Test System (Onera STS) (April 6, 2022)

Other clearances for product code MNR

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  • K252383 — Somfit D (August 28, 2025)
  • K242224 — Happy Health Home Sleep Test (June 18, 2025)
  • K243092 — AcuPebble Ox (200) (March 19, 2025)
  • K243268 — TipTraQ (TTQ001) (February 3, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K242290 — DormoTech NLab (January 8, 2025)
  • K242424 — Bluebird Single-Use Respiratory Effort Belt (December 18, 2024)