The following data is part of a premarket notification filed by Amc Health with the FDA for Amc Health Vitalcaregiving System.
| Device ID | K151839 |
| 510k Number | K151839 |
| Device Name: | AMC Health VitalCaregiving System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | AMC Health 39 Broadway, Suite 540 New York, NY 10006 |
| Contact | Jonathan Shankman |
| Correspondent | Jonathan Shankman AMC Health 39 Broadway, Suite 540 New York, NY 10006 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2016-09-09 |
| Summary: | summary |