The following data is part of a premarket notification filed by Advanced Instumentations, Inc. with the FDA for Cms-2000 Central Monitoring System.
| Device ID | K172966 |
| 510k Number | K172966 |
| Device Name: | CMS-2000 Central Monitoring System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Advanced Instumentations, Inc. 6800 NW 77th. Ct. Miami, FL 33166 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan Advanced Instumentations, Inc. 6800 NW 77th. Ct. Miami, FL 33166 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2017-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510CMS20001 | K172966 | 000 |