The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Carescape R860.
| Device ID | K142679 |
| 510k Number | K142679 |
| 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 Dwyer |
| Correspondent | Trishia Dwyer 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 | 2014-09-19 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102346 | K142679 | 000 |