Ohio 5400 Volume Monitor
FDA 510(k) K832565 · Airco/Ohio Medical Products
510(k) numberK832565
Submission
- Device name
- Ohio 5400 Volume Monitor
- Applicant
- Airco/Ohio Medical Products
Mchenry, IL, US - Received
- August 2, 1983
- Decision date
- September 1, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZK – Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1850
- Specialty
- Anesthesiology
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More from Respironics Novametrix, Inc.
| 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 |
| K832185 | Ohio Model 922 SpirometerBZG · Traditional | 08/12/1983SE |
| 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 5400 Volume Monitor cleared by the FDA?
Ohio 5400 Volume Monitor (K832565) received a 510(k) decision of Substantially Equivalent on September 1, 1983, 30 days after the submission was received.
What is the product code of K832565?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.