The following data is part of a premarket notification filed by Mindray North America with the FDA for Accutorr 7 Vital Signs Monitor.
| Device ID | K132038 |
| 510k Number | K132038 |
| Device Name: | ACCUTORR 7 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 |
| 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 | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089478 | K132038 | 000 |
| 06944904090658 | K132038 | 000 |
| 06944904090641 | K132038 | 000 |
| 06944904090634 | K132038 | 000 |
| 06944904090627 | K132038 | 000 |
| 06944904061306 | K132038 | 000 |
| 06944904006130 | K132038 | 000 |
| 06944904006109 | K132038 | 000 |
| 06944904005942 | K132038 | 000 |
| 06944904005904 | K132038 | 000 |
| 06944904003818 | K132038 | 000 |
| 06944904003801 | K132038 | 000 |
| 06944904090665 | K132038 | 000 |
| 06944904090672 | K132038 | 000 |
| 06944904090689 | K132038 | 000 |
| 06944904086897 | K132038 | 000 |
| 06944904086262 | K132038 | 000 |
| 06944904085746 | K132038 | 000 |
| 06944904085722 | K132038 | 000 |
| 06944904064772 | K132038 | 000 |
| 06944904064765 | K132038 | 000 |
| 06944904064758 | K132038 | 000 |
| 06944904064741 | K132038 | 000 |
| 06944904064734 | K132038 | 000 |
| 06944904064727 | K132038 | 000 |
| 06944904064710 | K132038 | 000 |
| 06944904003771 | K132038 | 000 |