The following data is part of a premarket notification filed by Mindray North America with the FDA for Vital Signs Monitor.
| Device ID | K132037 |
| 510k Number | K132037 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | MINDRAY NORTH AMERICA 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen MINDRAY NORTH AMERICA 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2014-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904085739 | K132037 | 000 |
| 06944904085715 | K132037 | 000 |