DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
FDA 510(k) clearance K052582 · decided 2005-10-14
Clearance details
- K-number
- K052582
- Device name
- DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2005-09-20
- Decision date
- 2005-10-14
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM F recall (Z-2068-2014) | GE Healthcare, LLC | 2014-07-18 |
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|---|---|---|
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| 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 |
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