The following data is part of a premarket notification filed by Vega Technologies, Inc. with the FDA for Vega Cpap System/heated Humidifier, Model Cp-03.
| Device ID | K102625 |
| 510k Number | K102625 |
| Device Name: | VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104 |
| Contact | Joseph Lu |
| Correspondent | Joseph Lu VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-13 |
| Decision Date | 2011-06-10 |
| Summary: | summary |