The following data is part of a premarket notification filed by Shenzhen Ivankaca Technology Co., Ltd with the FDA for Ultrasonic Mesh Nebulizer.
| Device ID | K201397 |
| 510k Number | K201397 |
| Device Name: | Ultrasonic Mesh Nebulizer |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Shenzhen Ivankaca Technology Co., Ltd 3/F, Building B, No. 45 Lixin Road, NanWan, Longgang, Shenzhen, Guangdong Shenzhen, CN 518100 |
| Contact | Sam Wong |
| Correspondent | Long Yang Shenzhen Hlongmed Biotech Co., Ltd. 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C Shenzhen, CN 518054 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-28 |
| Decision Date | 2021-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971209160090 | K201397 | 000 |
| 06971209160083 | K201397 | 000 |