CARESCAPE R860
FDA 510(k) clearance K142679 · decided 2015-06-12
Clearance details
- K-number
- K142679
- Device name
- CARESCAPE R860
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-19
- Decision date
- 2015-06-12
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators ( recall (Z-1226-2022) | GE Healthcare, LLC | 2022-06-06 |
| Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, E recall (Z-1227-2022) | GE Healthcare, LLC | 2022-06-06 |
| CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electro recall (Z-2883-2020) | GE Healthcare, LLC | 2020-08-24 |
| GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (singl recall (Z-0463-2019) | GE Healthcare, LLC | 2018-11-30 |
| CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 recall (Z-2266-2018) | Datex-Ohmeda, Inc. | 2018-06-01 |