The following data is part of a premarket notification filed by Cerner Corp. with the FDA for Cerner Careaware Ibus.
| Device ID | K093134 |
| 510k Number | K093134 |
| Device Name: | CERNER CAREAWARE IBUS |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
| Contact | Shelley S Looby |
| Correspondent | Shelley S Looby CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2009-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853023006128 | K093134 | 000 |
| 00853023006012 | K093134 | 000 |