The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Ultrasonic Nebulizer (mesh Type).
| Device ID | K121520 |
| 510k Number | K121520 |
| Device Name: | ULTRASONIC NEBULIZER (MESH TYPE) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., NEW TAIPEI INDUST PARK New Taipei, TW 24890 |
| Contact | Jm Lin |
| Correspondent | Jm Lin K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., NEW TAIPEI INDUST PARK New Taipei, TW 24890 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-22 |
| Decision Date | 2013-03-15 |
| Summary: | summary |