East-Freeman Ventilator Mark 2
FDA 510(k) K812958 · Cairco , Ltd.
510(k) numberK812958
Submission
- Device name
- East-Freeman Ventilator Mark 2
- Applicant
- Cairco , Ltd.
Mchenry, IL, US - Received
- October 21, 1981
- Decision date
- January 7, 1982
- 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
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| 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 |
|---|---|---|
| K812961 | Sheffield Infant Ventilator Mark 4CBK · Traditional | 03/26/1982SE |
| K812957 | East Autoclave HumidifierBTT · Traditional | 03/12/1982SE |
| K812959 | Spirox aBZK · Traditional | 01/22/1982SE |
| K812956 | Spirox HBZK · Traditional | 01/22/1982SE |
| K812955 | East Water Unit Mark 3DWJ · Traditional | 12/29/1981SE |
| K812953 | Radcliffe Ventilator Mark 5CBK · Traditional | 11/27/1981SE |
| K812960 | East Ventilarm Pressure Monitor Alarm S.CAP · Traditional | 11/16/1981SE |
| K810640 | Polarised Light GroniometerKQX · Traditional | 04/17/1981SE |
Questions and answers
When was East-Freeman Ventilator Mark 2 cleared by the FDA?
East-Freeman Ventilator Mark 2 (K812958) received a 510(k) decision of Substantially Equivalent on January 7, 1982, 78 days after the submission was received.
What is the product code of K812958?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.