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510(k) K201495

Maxxi Flow Sensor by Neurovirtual USA, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2020
Date Received
June 5, 2020
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 Neurovirtual USA, Inc.

  • K191492 — Maxxi Position Sensor (April 24, 2020)
  • K191095 — Maxxi Snore Sensor (January 16, 2020)
  • K171304 — Maxxi Rip Sensor (June 24, 2019)
  • K163547 — MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (April 11, 2017)
  • K131335 — BWMINI EEG, BWMINIHST, BWMINI PSG (February 3, 2015)
  • K112107 — BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS (October 28, 2011)
  • K062533 — BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 (December 22, 2006)

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  • 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)