ULTRASONIC NEBULIZER
Nebulizer (direct Patient Interface)
FOSHAN GAUNYING ELECTRONICS CO., LTD.
The following data is part of a premarket notification filed by Foshan Gaunying Electronics Co., Ltd. with the FDA for Ultrasonic Nebulizer.
Pre-market Notification Details
| Device ID | K121154 |
| 510k Number | K121154 |
| Device Name: | ULTRASONIC 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-08-20 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20852547004058 | K121154 | 000 |
| 00810025921033 | K121154 | 000 |
Trademark Results [ULTRASONIC NEBULIZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRASONIC NEBULIZER 72212511 0809999 Dead/Expired |
DE VILBISS COMPANY, THE 1965-02-23 |
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