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510(k) K250460

WatchPAT400 (WP400) by Itamar Medical , Ltd. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2025
Date Received
February 18, 2025
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 Itamar Medical , Ltd.

  • K223675 — WatchPAT ONE (WP1) (January 6, 2023)
  • K211557 — EndoPATx (December 29, 2022)
  • K222331 — WatchPAT300 (WP300) (September 14, 2022)
  • K203839 — WatchPAT200U (WP200U) (March 21, 2022)
  • K183559 — WatchPAT ONE (June 5, 2019)
  • K180775 — Watch-PAT300 (August 17, 2018)
  • K161579 — Watch-PAT200U (February 24, 2017)
  • K153070 — Watch-PAT200U (July 26, 2016)
  • K133859 — WATCH-PAT200U (WP200U) (May 30, 2014)
  • K102567 — WATCH-PAT 200S-3 (WP200S-3) (June 2, 2011)

Other clearances for product code MNR

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  • K250882 — SANSA HSAT (October 29, 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)
  • K242424 — Bluebird Single-Use Respiratory Effort Belt (December 18, 2024)