Arf 850 E
FDA 510(k) K831877 · W.E. Leder Enterprises, Inc.
510(k) numberK831877
Submission
- Device name
- Arf 850 E
- Applicant
- W.E. Leder Enterprises, Inc.
Mchenry, IL, US - Received
- June 13, 1983
- Decision date
- November 3, 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
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| 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 |
|---|---|---|
| K831981 | LaryngescopeCCW · Traditional | 09/29/1983SE |
| K831878 | Cardio-Scope Mini MonitorDPS · Traditional | 09/29/1983SE |
| K830161 | Anesthesia Apatatus #D-25BSZ · Traditional | 03/09/1983SE |
| K830160 | Anesthesia Apparatus #Fo 20SBSZ · Traditional | 03/09/1983SE |
| K830159 | Anesthesia Apparatus PH-35BSZ · Traditional | 03/09/1983SE |
Questions and answers
When was Arf 850 E cleared by the FDA?
Arf 850 E (K831877) received a 510(k) decision of Substantially Equivalent on November 3, 1983, 143 days after the submission was received.
What is the product code of K831877?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.