The following data is part of a premarket notification filed by Cerner Corporation with the FDA for Cerner Careaware Event Management.
| Device ID | K151672 |
| 510k Number | K151672 |
| Device Name: | Cerner CareAware Event Management |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | CERNER CORPORATION 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
| Contact | Shelley S. Looby |
| Correspondent | Shelley S. Looby CERNER CORPORATION 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-22 |
| Decision Date | 2015-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853023006135 | K151672 | 000 |
| 00853023006111 | K151672 | 000 |