Isolette 8000 Plus
FDA 510(k) clearance K182977 · decided 2018-11-21
Clearance details
- K-number
- K182977
- Device name
- Isolette 8000 Plus
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-26
- Decision date
- 2018-11-21
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- FMZ
- Device class
- 2
- Regulation number
- 880.5400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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| Infant Incubator (K190494) | Ningbo David Medical Device Co., Ltd. | 2019-11-25 |
| Babyleo TN500 (K182859) | Dragerwerk AG & CO Kgaa | 2019-02-22 |
| Isolette 8000 plus (K172154) | Draeger Medical Sytems, Inc. | 2018-04-19 |
| Babyleo TN500 (K162821) | Draegerwerk AG & CO Kgaa | 2017-06-23 |
| Giraffe OmniBed Carestation CS1 (K152814) | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016-03-17 |
| Giraffe Incubator Carestation CS1 (K152809) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 |
| INFANT INCUBATOR (K132543) | Bistos Co., Ltd. | 2014-07-03 |
Recalls involving this device
No recalls on record reference this clearance.