Evita 4 (8411900)
FDA 510(k) K980642 · Drager, Inc.
510(k) numberK980642
Submission
- Device name
- Evita 4 (8411900)
- Applicant
- Drager, Inc.
Telford, PA, US - Received
- February 19, 1998
- Decision date
- September 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K992608 | Atc Option for Evita 2 Dura and Evita 4CBK · Special | 08/24/1999SE |
| K984577 | Drager Oxylog 2000CBK · Special | 01/22/1999SE |
| K983219 | Neoflow Option Model Numbers 8413563, 8411900CBK · Traditional | 12/07/1998SE |
| K982789 | Medical Air Compressor, Model # 8413419BTI · Traditional | 10/29/1998SE |
| K974176 | Babylog 8000 PlusCBK · Traditional | 06/17/1998SE |
| K971198 | Babytherm 8004 Babytherm 8010FMT · Traditional | 10/03/1997SE |
| K970165 | Evita 2 DuraCBK · Traditional | 08/26/1997ST |
| K954204 | Drager Incubator 8000 IcFMZ · Traditional | 04/25/1997SE |
| K961687 | Evita 4CBK · Traditional | 12/13/1996ST |
| K950853 | Optional Display and Software for Drager VentilatorsCBK · Traditional | 11/05/1996ST |
Questions and answers
When was Evita 4 (8411900) cleared by the FDA?
Evita 4 (8411900) (K980642) received a 510(k) decision of Substantially Equivalent on September 4, 1998, 197 days after the submission was received.
What is the product code of K980642?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.