BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
FDA 510(k) clearance K003251 · decided 2001-05-23
Clearance details
- K-number
- K003251
- Device name
- BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
- Applicant
- Blease Medical Equipment , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-17
- Decision date
- 2001-05-23
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFo recall (Z-0352-2014) | Del Mar Reynolds Medical, Ltd. | 2013-11-20 |
| Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS recall (Z-0968-2013) | Del Mar Reynolds Medical, Ltd. | 2013-03-20 |
| BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machi recall (Z-0565-2013) | Del Mar Reynolds Medical, Ltd. | 2012-12-19 |