Newport C250 Air Compressor Model C250
FDA 510(k) K041406 · Newport Medical Instruments
510(k) numberK041406
Submission
- Device name
- Newport C250 Air Compressor Model C250
- Applicant
- Newport Medical Instruments
Costa Mesa, CA, US - Received
- May 26, 2004
- Decision date
- December 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
Other 510(k)s with product code BTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131881 | Ombra Table Top CompressorBTI · Traditional | Trudell Medical Intl. | 10/24/2013SE |
| K113338 | Medical Air CompressorBTI · Traditional | Oricare, Inc. | 08/10/2012SE |
| K091871 | DK50 DSBTI · Special | Ekom S.R.O. | 10/23/2009SE |
| K072634 | Emg Triton -Comp,Model NCA01-XXX SeriesBTI · Traditional | Emg Technology Co., Ltd. | 11/19/2008SE |
| K060781 | Medical Compressor, Models DK50 D and DMBTI · Traditional | Ekom S.R.O. | 10/03/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | Precision Medical, Inc. | 12/09/2005SE |
| K041781 | Ventilair II Medical Air CompressorBTI · Traditional | Hamilton Medical AG | 03/14/2005SE |
| K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerBTI · Special | Med2000 S.R.L. | 08/24/2004SE |
| K040220 | Medical Air CompressorBTI · Traditional | eVent Medical, Ltd. | 06/09/2004SE |
| K031686 | Aeromist LT, Model HCS15004BTI · Traditional | Medline Industries, Inc. | 01/21/2004SE |
More from Medline Industries, Inc.
| 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 |
| 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 C250 Air Compressor Model C250 cleared by the FDA?
Newport C250 Air Compressor Model C250 (K041406) received a 510(k) decision of Substantially Equivalent on December 15, 2004, 203 days after the submission was received.
What is the product code of K041406?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.