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510(k) K223573

Onera Sleep Test System (Onera STS) by Onera B.V. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
November 30, 2022
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.

  • K253668 — Onera SleepMap (SLEEPMAP) (March 8, 2026)
  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 2025)
  • K210593 — Onera Sleep Test System (Onera STS) (April 6, 2022)

Other clearances for product code MNR

  • K252497 — SANSA HSAT (December 10, 2025)
  • K250882 — SANSA HSAT (October 29, 2025)
  • K250460 — WatchPAT400 (WP400) (September 5, 2025)
  • K252383 — Somfit D (August 28, 2025)
  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 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)