VS-200S Jet Ventilator
FDA 510(k) K900745 · Acutronic Medical Systems AG
510(k) numberK900745
Submission
- Device name
- VS-200S Jet Ventilator
- Applicant
- Acutronic Medical Systems AG
Jona-Rapper Swril, CH - Received
- February 16, 1990
- Decision date
- April 29, 1991
- 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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| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
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| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K012691 | Monsoon Critical Care Jet Ventilator and AccessoriesCBK · Traditional | 12/20/2002SE |
| K012693 | Mistral Critical Care Jet Ventilator and AccessoriesCBK · Traditional | 08/01/2002SE |
| K936009 | Ams 3000MCAP · Traditional | 05/03/1995SE |
| K900744 | Ams 3000 Portable Jet VentilatorCBK · Traditional | 04/29/1991SE |
| K883865 | External Jet Synchronizer, Model AMS-1010CBK · Traditional | 06/08/1989SE |
| K863155 | Universal Jet Ventilator Model AMS-1000CBK · Traditional | 09/28/1987SE |
| K863154 | Heated Jet Humidifier Model AMS-1020BTT · Traditional | 01/12/1987SE |
| K862436 | Trans- Circothyrotomy Device (Acc. Ravussin)BTO · Traditional | 11/03/1986SE |
| K862435 | Double Lumen E T AdaptorBZA · Traditional | 10/22/1986SE |
| K862433 | Uni-Jet ConnectorBZA · Traditional | 08/06/1986SE |
Questions and answers
When was VS-200S Jet Ventilator cleared by the FDA?
VS-200S Jet Ventilator (K900745) received a 510(k) decision of Substantially Equivalent on April 29, 1991, 437 days after the submission was received.
What is the product code of K900745?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.