The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Carescape R860.
| Device ID | K210384 |
| 510k Number | K210384 |
| Device Name: | CARESCAPE R860 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison, WI 53707 -7550 |
| Contact | Trishia Mercier |
| Correspondent | Monica Morrison Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison, WI 53707 -7550 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-09 |
| Decision Date | 2021-11-04 |