The following data is part of a premarket notification filed by Baymax Research, Inc. with the FDA for Mimo(tm) Negative Pressure Wound Therapy System.
| Device ID | K181929 |
| 510k Number | K181929 |
| Device Name: | MiMo(TM) Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Baymax Research, Inc. 315 W36th St New York, NY 10018 |
| Contact | Richard Chen |
| Correspondent | Richard Chen Baymax Research, Inc. 315 W36th St New York, NY 10018 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-18 |
| Decision Date | 2019-03-27 |