Home / 510(k) Clearances / K950331

510(k) K950331

PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) by Healthdyne, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1995
Date Received
January 27, 1995
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 Healthdyne, Inc.

  • K922106 — ALICE (July 6, 1994)
  • K942357 — H-500 ALLIANCE OXYGEN CONCENTRATOR (May 27, 1994)
  • K934502 — FLOW SPIROMETER (April 4, 1994)
  • K924146 — OH-500 OXYGEN CONCENTRATOR (January 7, 1993)
  • K922623 — NEBULIZER SYSTEM (December 1, 1992)
  • K910118 — DATA RECORDER (February 14, 1991)
  • K903287 — MODEL 900S APNEA/HEART MONITOR (August 17, 1990)
  • K894030 — MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR (January 22, 1990)
  • K892006 — HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S (May 23, 1989)
  • K890150 — H-3000 OXYGEN CONCENTRATOR (January 31, 1989)

Other clearances for product code BZD

  • K252338 — MySleepDash (April 17, 2026)
  • 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)