Vega CPAP System/Heated Humidifier, Model CP-03
FDA 510(k) K102625 · Vega Technologies, Inc.
510(k) numberK102625
Submission
- Device name
- Vega CPAP System/Heated Humidifier, Model CP-03
- Applicant
- Vega Technologies, Inc.
Taipei, TW - Received
- September 13, 2010
- Decision date
- June 10, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
| K253939 | DeltaWave Nasal Pillow SystemBZD · Special | RemSleep Holdings, Inc. | 01/07/2026SE |
| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K102934 | Infrared Ear Thermometer, Model IR-04MTFLL · Traditional | 01/14/2011SE |
| K102626 | Vega Medical Suction Equipment, Model SU-01/SU-DC01JCX · Traditional | 11/12/2010SE |
| K041516 | Digital Thermometer, Models MT-XX8 and MT-XX9FLL · Traditional | 09/08/2004SE |
| K031413 | Vigormist Compressor NebulizerBTI · Traditional | 10/07/2003SE |
| K002831 | Vega Ultrasonic NebulizerCAF · Traditional | 05/23/2001SE |
Questions and answers
When was Vega CPAP System/Heated Humidifier, Model CP-03 cleared by the FDA?
Vega CPAP System/Heated Humidifier, Model CP-03 (K102625) received a 510(k) decision of Substantially Equivalent on June 10, 2011, 270 days after the submission was received.
What is the product code of K102625?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.