Home / 510(k) Clearances / K242935

510(k) K242935

Respiration Data Management Software (PAP Link PC) by BMC Medical Co., Ltd. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2025
Date Received
September 25, 2024
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 BMC Medical Co., Ltd.

  • K213169 — BPAP System (December 5, 2022)
  • K211155 — Auto CPAP System (March 9, 2022)
  • K133009 — NASAL MASK, NASAL MASK, FULL FACE MASK (April 23, 2014)

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)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)
  • K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face V (October 18, 2024)