The following data is part of a premarket notification filed by Foshan Gaunying Electronics Co., Ltd. with the FDA for Ultrasonic Mesh Nebulizer.
| Device ID | K140211 |
| 510k Number | K140211 |
| Device Name: | ULTRASONIC MESH NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | FOSHAN GAUNYING ELECTRONICS CO., LTD. 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Contact | Guenter Ginsberg |
| Correspondent | Guenter Ginsberg FOSHAN GAUNYING ELECTRONICS CO., LTD. 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-28 |
| Decision Date | 2014-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863943000120 | K140211 | 000 |