GE Datex-Ohmeda Engstrom Carestation
FDA 510(k) K062710 · Datex-Ohmeda, Inc.
510(k) numberK062710
Submission
- Device name
- GE Datex-Ohmeda Engstrom Carestation
- Applicant
- Datex-Ohmeda, Inc.
Madison, WI, US - Received
- September 11, 2006
- Decision date
- December 8, 2006
- 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
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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 |
|---|---|---|
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | 08/10/2026SE |
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | 07/28/2026SE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | 10/22/2025SE |
| K231964 | Novii+ Wireless Patch SystemHGM · Traditional | 12/08/2023SE |
| K213867 | Carestation 750/750cBSZ · Traditional | 03/28/2023SE |
| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | 03/02/2022SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | 03/02/2022SE |
| K210384 | Carescape R860CBK · Traditional | 11/04/2021SE |
| K172702 | Tec 820, Tec 850CAD · Traditional | 01/04/2018SE |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional | 11/03/2017SE |
Questions and answers
When was GE Datex-Ohmeda Engstrom Carestation cleared by the FDA?
GE Datex-Ohmeda Engstrom Carestation (K062710) received a 510(k) decision of Substantially Equivalent on December 8, 2006, 88 days after the submission was received.
What is the product code of K062710?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.