The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Accutorr 7/vs-900/vs-900c Vital Signs Monitor.
| Device ID | K182821 |
| 510k Number | K182821 |
| Device Name: | Accutorr 7/VS-900/VS-900c Vital Signs Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Shenzhen Mindray Bio-medical Electronics Co., LTD. Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Yanhong Bai |
| Correspondent | Yanhong Bai Shenzhen Mindray Bio-medical Electronics Co., LTD. Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Product Code | MWI |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-04 |
| Decision Date | 2019-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904005317 | K182821 | 000 |
| 06944904005959 | K182821 | 000 |
| 06944904005980 | K182821 | 000 |
| 06944904005966 | K182821 | 000 |
| 06944904005973 | K182821 | 000 |
| 06944904005270 | K182821 | 000 |
| 06944904005287 | K182821 | 000 |
| 06944904005294 | K182821 | 000 |
| 06944904005300 | K182821 | 000 |
| 00860002604404 | K182821 | 000 |