The following data is part of a premarket notification filed by Nuvon, Inc. with the FDA for Nuvon Vitals Charting System.
| Device ID | K130234 |
| 510k Number | K130234 |
| Device Name: | NUVON VITALS CHARTING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | NUVON, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan NUVON, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-30 |
| Decision Date | 2013-03-13 |
| Summary: | summary |