The following data is part of a premarket notification filed by Suzhou Minhua Medical Apparatus Supplies Co. Ltd. with the FDA for Venera 508 Deep Vein Thrombosis (dvt) Prevention System.
| Device ID | K180389 |
| 510k Number | K180389 |
| Device Name: | Venera 508 Deep Vein Thrombosis (DVT) Prevention System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Suzhou Minhua Medical Apparatus Supplies Co. Ltd. No.789, Wu Fang Road, Friendship Industrial Zone Song Ling Town, Wu Jiang Suzhou, CN 215222 |
| Contact | Michael Ying |
| Correspondent | Alex Wang Suzhou Minhua Medical Apparatus Supplies Co. Ltd. No.789, Wu Fang Road, Friendship Industrial Zone Song Ling Town, Wu Jiang Suzhou, CN 215222 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-13 |
| Decision Date | 2018-06-29 |
| Summary: | summary |