Home / 510(k) Clearances / K970173

510(k) K970173

MODEL 1700 TRANQUILITY BILEVEL SYSTEM by Healthdyne Technologies, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1997
Date Received
January 16, 1997
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 Technologies, Inc.

  • K983572 — SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 (March 19, 1999)
  • K974453 — NASAL INTERFACE MODEL 7910 (August 4, 1998)
  • K974879 — MODEL 7410 VOYAGER (June 29, 1998)
  • K972614 — TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 6 (January 20, 1998)
  • K971867 — ALICE 4R SYSTEM (August 13, 1997)
  • K971545 — PROTEGE LIQUID OXYGEN SYSTEM (July 25, 1997)
  • K962517 — MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV (February 20, 1997)
  • K943509 — 7300 NASAL CPAP SYSTEM (August 5, 1994)

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)