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510(k) K001013

MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY by Airsep Corp. — Product Code OLV

K001013 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY". The FDA issued a decision of Substantially Equivalent on May 16, 2000. The device falls under product code OLV (Standard Polysomnograph With Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Airsep Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2000
Date Received
March 29, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Standard Polysomnograph With Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

Other clearances by Airsep Corp.

  • K101154 — CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L (March 28, 2011)
  • K080348 — OXISCAN II DATA MANAGEMENT SYSTEM (October 9, 2008)
  • K020324 — LIFESTYLE OXYGEN CONCENTRATOR (March 13, 2002)
  • K012037 — HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 (January 17, 2002)
  • K000963 — DA VINCHI EEG AND EMG/EP SYSTEMS (October 20, 2000)
  • K001579 — IMPULSE SELECT (August 31, 2000)
  • K001467 — DA VINCHI EMG/EP ISA1004EP (August 1, 2000)
  • K992283 — ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (August 27, 1999)
  • K983002 — MYSTIQUE ULTRASONIC NEBULIZER (October 16, 1998)
  • K960309 — AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) (February 28, 1997)

Other clearances for product code OLV

  • K260585 — Noxturnal Web (March 20, 2026)
  • K242447 — Falcon HST (February 20, 2025)
  • K241288 — Noxturnal Web (December 23, 2024)
  • K240700 — HomeSleepTest (HST, HST REM+) (December 8, 2024)
  • K213007 — Cerebra Sleep System (July 6, 2022)
  • K201054 — SOMNOscreen plus (August 12, 2020)
  • K192624 — ApneaTrak (February 20, 2020)
  • K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor (November 16, 2018)
  • K173868 — Serenity Body Position Sensor, Serenity RIP Sensors (July 2, 2018)
  • K173690 — Grass TWin (March 9, 2018)

FDA data resources