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510(k) K191095

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2020
Date Received
April 25, 2019
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.

  • K201495 — Maxxi Flow Sensor (December 14, 2020)
  • K191492 — Maxxi Position Sensor (April 24, 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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