The following data is part of a premarket notification filed by Ding Hwa Co., Ltd. with the FDA for Dv-300 Aspirator.
| Device ID | K181398 |
| 510k Number | K181398 |
| Device Name: | DV-300 Aspirator |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | Ding Hwa Co., Ltd. No. 121, Sec. 3, Zhongshan Rd. Dacun, TW 51542 |
| Contact | Eric Han |
| Correspondent | John Macmahon V2K Medical, Inc. 1221 Innsbruck Drive Sunnyvale, CA 94089 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2018-07-23 |
| Summary: | summary |