Home / 510(k) Clearances / K943207

510(k) K943207

NITELIFE BI-LEVEL CPAP by Airsep Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1996
Date Received
July 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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)
  • K001013 — MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (May 16, 2000)
  • K992283 — ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (August 27, 1999)
  • K983002 — MYSTIQUE ULTRASONIC NEBULIZER (October 16, 1998)

Other clearances for product code BZD

  • K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (January 15, 2026)
  • K253939 — DeltaWave Nasal Pillow System (January 7, 2026)
  • K251770 — SleepRes PAP System (December 15, 2025)
  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K243583 — F&P Nova Nasal Mask (June 18, 2025)
  • K250624 — myAir (May 28, 2025)
  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
  • K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)
  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)