Home / 510(k) Clearances / K813476

510(k) K813476

OHIO VOLUME INCENTIVE SPIROMETER by Airco/Ohio Medical Products — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 1, 1981
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 Airco/Ohio Medical Products

  • K833459 — COAXIAL VOL. VENTILATOR CIRCUIT (January 10, 1984)
  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K832418 — OHIO TEMPERATURE SIMULATOR (September 12, 1983)
  • K832565 — OHIO 5400 VOLUME MONITOR (September 1, 1983)
  • K832185 — OHIO MODEL 922 SPIROMETER (August 12, 1983)
  • K830446 — OXYGEN MONITOR OHIO 5100 (March 24, 1983)
  • K822456 — OHIO V5A ANESTHESIA VENTILATOR (September 21, 1982)
  • K812879 — OHIO NON-REUSABLE TRACHEAL TUBE MURPHY (November 24, 1981)
  • K812880 — OHIO NON-REUSABLE TRACHEAL TUBE MAJILL (November 24, 1981)
  • K811413 — DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR (June 2, 1981)

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)