Ohio Model 922 Spirometer
FDA 510(k) K832185 · Airco/Ohio Medical Products
510(k) numberK832185
Submission
- Device name
- Ohio Model 922 Spirometer
- Applicant
- Airco/Ohio Medical Products
Mchenry, IL, US - Received
- July 6, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
Other 510(k)s with product code BZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251777 | MESI mTABLET SPIROBZG · Traditional | Mesi D.O.O. | 03/02/2026SE |
| K241843 | TD-7301 Spirometer (TD-7301)BZG · Traditional | Gostar Co., Ltd. | 11/20/2024SE |
| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
| K230501 | Spirobank OxiBZG · Traditional | Mir Medical International Research USA | 12/15/2023SE |
| K230178 | EasyOne Sky SpirometerBZG · Traditional | Ndd Medizintechnik AG | 10/19/2023SE |
| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
| K222443 | Air Smart Extra SpirometerBZG · Traditional | Feellife Health, Inc. | 08/09/2023SE |
| K213754 | SpiroHome Personal, SpiroHome ClinicBZG · Traditional | Inofab Saglik Teknolojileri A.S | 06/12/2023SE |
| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
More from Vitalograph Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K833459 | Coaxial Vol. Ventilator CircuitBZO · Traditional | 01/10/1984SE |
| K833452 | Ohio GMS AbsorberBSF · Traditional | 11/29/1983SE |
| K832418 | Ohio Temperature SimulatorFMZ · Traditional | 09/12/1983SE |
| K832565 | Ohio 5400 Volume MonitorBZK · Traditional | 09/01/1983SE |
| K830446 | Oxygen Monitor Ohio 5100CCL · Traditional | 03/24/1983SE |
| K822456 | Ohio V5A Anesthesia VentilatorCBK · Traditional | 09/21/1982SE |
| K813476 | Ohio Volume Incentive SpirometerBWF · Traditional | 12/31/1981SE |
| K812880 | Ohio Non-Reusable Tracheal Tube MajillBTR · Traditional | 11/24/1981SE |
| K812879 | Ohio Non-Reusable Tracheal Tube MurphyBTR · Traditional | 11/24/1981SE |
| K811413 | Dabc Nonconductive Pediat. Anesth. CirCAI · Traditional | 06/02/1981SE |
Questions and answers
When was Ohio Model 922 Spirometer cleared by the FDA?
Ohio Model 922 Spirometer (K832185) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 37 days after the submission was received.
What is the product code of K832185?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.