The following data is part of a premarket notification filed by Critical Alert with the FDA for Critical Alert Commonpath Enterprise.
| Device ID | K193043 |
| 510k Number | K193043 |
| Device Name: | Critical Alert CommonPath Enterprise |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Critical Alert 4901 Belfort Road, Suite 130 Jacksonville, FL 32256 |
| Contact | John Elms |
| Correspondent | Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-31 |
| Decision Date | 2020-05-11 |