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510(k) K244027

SANSA HSAT by Huxley Medical — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2025
Date Received
December 30, 2024
Clearance Type
Special
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 Huxley Medical

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  • K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00) (July 15, 2024)

Other clearances for product code MNR

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  • 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)
  • K242290 — DormoTech NLab (January 8, 2025)
  • K242424 — Bluebird Single-Use Respiratory Effort Belt (December 18, 2024)