Ventilator #1
FDA 510(k) K830488 · Ohio Medical Products
510(k) numberK830488
Submission
- Device name
- Ventilator #1
- Applicant
- Ohio Medical Products
Walker, MI, US - Received
- February 15, 1983
- Decision date
- September 15, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600)CBK · Traditional | Draegerwerk AG & CO Kgaa | 05/07/2026SE |
| K252663 | Inbentus VersatileCBK · Traditional | Iconic Solutions by Murcia, SL | 04/14/2026SE |
| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K841733 | Ohio Waste Gas Scavenging ReservoirCBN · Traditional | 07/11/1984SE |
| K842003 | Ohio Waste Gas Scavenging InterfaceCBN · Traditional | 05/23/1984SE |
| K840356 | Ohio Unitrol II Anesthesia Gas MachineBSZ · Traditional | 04/20/1984SE |
| K841274 | Bag-To-Ventilator Selector ValveBSZ · Traditional | 04/13/1984SE |
| K840967 | Ohio Heat Reflecting PatchFMI · Traditional | 03/23/1984SE |
| K840858 | Ohio 3300 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840857 | Ohio 3000 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840453 | Medishield PVM RespirometerBZK · Traditional | 03/02/1984SE |
| K840452 | Premium Dabm Dispos. Anes. Breath MaskBSJ · Traditional | 02/17/1984SE |
| K833335 | Modulus II Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
Questions and answers
When was Ventilator #1 cleared by the FDA?
Ventilator #1 (K830488) received a 510(k) decision of Substantially Equivalent on September 15, 1983, 212 days after the submission was received.
What is the product code of K830488?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.