CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
FDA 510(k) clearance K123195 · decided 2013-02-28
Clearance details
- K-number
- K123195
- Device name
- CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
- Applicant
- GE Healthcare Finland Oy
- Decision
- Substantially Equivalent
- Date received
- 2012-10-11
- Decision date
- 2013-02-28
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- CCL
- Device class
- 2
- Regulation number
- 868.1720
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Helsinki, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CARESCAPE Respiratory Module E-sCO recall (Z-0754-2020) | GE Healthcare, LLC | 2020-01-10 |
| CARESCAPE Respiratory Module E-sCAiO recall (Z-0756-2020) | GE Healthcare, LLC | 2020-01-10 |
| CARESCAPE Respiratory Module E-sCAiOV recall (Z-0757-2020) | GE Healthcare, LLC | 2020-01-10 |
| CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the A recall (Z-2617-2014) | GE Healthcare, LLC | 2014-09-09 |