Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil
FDA 510(k) K992133 · Newport Medical Instruments, Inc.
510(k) numberK992133
Submission
- Device name
- Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil
- Applicant
- Newport Medical Instruments, Inc.
Costa Mesa, CA, US - Received
- June 23, 1999
- Decision date
- August 4, 2000
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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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More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K121891 | Newport Aura VentilatorCBK · Traditional | 11/09/2012SE |
| K111146 | Newport HT70 VentilatorCBK · Traditional | 12/01/2011SE |
| K101803 | Newport E360 VentilatorCBK · Special | 09/08/2010SE |
| K090888 | Newport HT70 Family of VentilatorsCBK · Traditional | 11/18/2009SE |
| K082724 | Newport HTS50 Ventilator with Dual Pac Battery SystemCBK · Traditional | 12/16/2008SE |
| 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 |
Questions and answers
When was Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil cleared by the FDA?
Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil (K992133) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on August 4, 2000, 408 days after the submission was received.
What is the product code of K992133?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.