The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Svm-7200 Series Vital Signs Monitor.
| Device ID | K190468 |
| 510k Number | K190468 |
| Device Name: | Nihon Kohden SVM-7200 Series Vital Signs Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo, JP 161-8560 |
| Contact | Thomas Bento |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-02-26 |
| Decision Date | 2019-05-28 |