Hamilton-C6
FDA 510(k) K201658 · Hamilton Medical AG
510(k) numberK201658
Submission
- Device name
- Hamilton-C6
- Applicant
- Hamilton Medical AG
Bonaduz, CH - Received
- June 18, 2020
- Decision date
- December 11, 2020
- 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
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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 |
|---|---|---|
| K201306 | HAMILTON-C3CBK · Traditional | 02/05/2021SE |
| K193228 | Hamilton-G5CBK · Traditional | 05/04/2020SE |
| K181216 | HAMILTON-T1, HAMILTON-C1CBK · Traditional | 08/02/2019SE |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010BTT · Traditional | 09/20/2017SE |
| K161450 | HAMILTON-C3CBK · Traditional | 04/27/2017SE |
| K153046 | HAMILTON-MR1CBK · Traditional | 09/06/2016SE |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010BTT · Traditional | 05/03/2016SE |
| K150893 | IntelliCuffBSK · Traditional | 01/29/2016SE |
| K140939 | HAMILTON-T1,HAMILTON-C1CBK · Traditional | 09/02/2015SE |
| K122438 | HAMILTON-MR1CBK · Abbreviated | 11/20/2013SE |
Questions and answers
When was Hamilton-C6 cleared by the FDA?
Hamilton-C6 (K201658) received a 510(k) decision of Substantially Equivalent on December 11, 2020, 176 days after the submission was received.
What is the product code of K201658?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.