The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Ultrasonic Nebulizer System, Model Kn-9210.
| Device ID | K083256 |
| 510k Number | K083256 |
| Device Name: | ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Contact | Jason Cheng |
| Correspondent | Jason Cheng K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-04 |
| Decision Date | 2009-06-26 |
| Summary: | summary |