Newport HTS50 Ventilator with Dual Pac Battery System
FDA 510(k) K082724 · Newport Medical Instruments, Inc.
510(k) numberK082724
Submission
- Device name
- Newport HTS50 Ventilator with Dual Pac Battery System
- Applicant
- Newport Medical Instruments, Inc.
Costa Mesa, CA, US - Received
- September 17, 2008
- Decision date
- December 16, 2008
- 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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| K121891 | Newport Aura VentilatorCBK · Traditional | 11/09/2012SE |
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| K090888 | Newport HT70 Family of VentilatorsCBK · Traditional | 11/18/2009SE |
| K061094 | Newport E500 Wave VentilatorCBK · Special | 07/28/2006SE |
| K053502 | Newport E360 VentilatorCBK · Special | 01/10/2006SE |
| K041406 | Newport C250 Air Compressor Model C250BTI · Traditional | 12/15/2004SE |
| K041082 | Newport Nebsonic N550 Ultrasonic NebulizerCAF · Traditional | 09/07/2004SE |
| K030780 | Newport E500 Wave VentilatorCBK · Traditional | 01/23/2004SE |
| K992133 | Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without…CBK · Traditional | 08/04/2000ST |
Questions and answers
When was Newport HTS50 Ventilator with Dual Pac Battery System cleared by the FDA?
Newport HTS50 Ventilator with Dual Pac Battery System (K082724) received a 510(k) decision of Substantially Equivalent on December 16, 2008, 90 days after the submission was received.
What is the product code of K082724?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.