The following data is part of a premarket notification filed by Hcmed Innovations Co., Ltd. with the FDA for Pulmogine Vibrating Mesh Nebulizer.
| Device ID | K202171 |
| 510k Number | K202171 |
| Device Name: | Pulmogine Vibrating Mesh Nebulizer |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HCMed Innovations Co., Ltd. Rm.B, 10F, No.319, Sec.2, Dunhua S. Rd., Da-an District, Taipei City, TW 10669 |
| Contact | Yiling Lee |
| Correspondent | Yiling Lee HCMed Innovations Co., Ltd. Rm.B, 10F, No.319, Sec.2, Dunhua S. Rd., Da-an District, Taipei City, TW 10669 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2021-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873130030 | K202171 | 000 |