DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
FDA 510(k) clearance K051092 · decided 2005-05-25
Clearance details
- K-number
- K051092
- Device name
- DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2005-04-28
- Decision date
- 2005-05-25
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- CCL
- Device class
- 2
- Regulation number
- 868.1720
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
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| 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 |
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