Home / 510(k) Clearances / K953055

510(k) K953055

MISTASSIST BREATHING EXERCISER by The Merlin Corp. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1996
Date Received
June 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

Other clearances by The Merlin Corp.

  • K942789 — MISTASSIST (August 12, 1994)

Other clearances for product code BWF

  • K241152 — InSee (August 21, 2025)
  • K233855 — AllPEP (February 2, 2024)
  • K221058 — LungTrainer (MD2 & MD3) (July 5, 2023)
  • K222018 — Breathe+ (June 2, 2023)
  • K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser (October 25, 2022)
  • K203378 — Pulsehaler (March 31, 2021)
  • K192000 — D R Burton OxyPAP (February 19, 2020)
  • K181660 — Acapella Choice Blue Vibratory PEP Device (October 24, 2019)
  • K183108 — Combined Aerobika OPEP and VersaPAP device (August 16, 2019)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)