The following data is part of a premarket notification filed by Benq Materials Corporation with the FDA for Anscare Simo Negative Pressure Wound Therapy (npwt) System.
| Device ID | K193185 |
| 510k Number | K193185 |
| Device Name: | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System |
| Classification | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Applicant | BenQ Materials Corporation No, 29, Jianguo E. Rd., Gueishan Taoyuan, TW 33341 |
| Contact | Miranda Chang |
| Correspondent | Isabel Tsai BenQ Materials Corporation 29 Jianguo E. Rd., Guishan Taoyuan, TW 33341 |
| Product Code | OKO |
| CFR Regulation Number | 878.4683 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2020-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719745008306 | K193185 | 000 |
| 04719745008184 | K193185 | 000 |
| 04719745008191 | K193185 | 000 |
| 04719745008207 | K193185 | 000 |
| 04719745008214 | K193185 | 000 |
| 04719745008221 | K193185 | 000 |
| 04719745008252 | K193185 | 000 |
| 04719745008269 | K193185 | 000 |
| 04719745008276 | K193185 | 000 |
| 04719745008283 | K193185 | 000 |
| 04719745008290 | K193185 | 000 |
| 04719745008177 | K193185 | 000 |