The following data is part of a premarket notification filed by Vega Technologies, Inc. with the FDA for Vega Ultrasonic Nebulizer.
| Device ID | K002831 |
| 510k Number | K002831 |
| Device Name: | VEGA ULTRASONIC NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| 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 | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-11 |
| Decision Date | 2001-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10767056403748 | K002831 | 000 |
| 10767056403663 | K002831 | 000 |
| 10767056403656 | K002831 | 000 |
| 10767056403113 | K002831 | 000 |
| 10767056403069 | K002831 | 000 |
| 10767056402758 | K002831 | 000 |
| 10767056043708 | K002831 | 000 |
| 10845717002858 | K002831 | 000 |