OHMEDA MEDICAL GIRAFFE OMNIBED
FDA 510(k) clearance K071175 · decided 2007-07-17
Clearance details
- K-number
- K071175
- Device name
- OHMEDA MEDICAL GIRAFFE OMNIBED
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2007-04-27
- Decision date
- 2007-07-17
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- FMZ
- Device class
- 2
- Regulation number
- 880.5400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Laurel, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (K260326) | Datex-Ohmeda, Inc. | 2026-07-28 |
| Babyleo TN500 (K251619) | Drägerwerk AG & Co. KGaA | 2026-02-13 |
| Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (K251663) | Datex-Ohmeda, Inc. | 2025-10-22 |
| mOm Essential Incubator (ME1) (K243437) | Mom Incubators Limited | 2025-08-14 |
| Giraffe Incubator Carestation CS1 (K213553) | Datex Ohmeda, Inc. | 2022-03-02 |
| 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 (K182977) | Draeger Medical Systems, Inc. | 2018-11-21 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |