BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
FDA 510(k) clearance K051629 · decided 2005-09-23
Clearance details
- K-number
- K051629
- Device name
- BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
- Applicant
- Blease USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-20
- Decision date
- 2005-09-23
- Days to decision
- 95 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capabili recall (Z-0813-2011) | Spacelabs Healthcare, Llc | 2010-12-27 |
| BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge recall (Z-2113-2010) | Spacelabs Healthcare, Llc | 2010-07-29 |
| The BleaseSirius and BleaseFocus Anaesthesia Systems. recall (Z-1408-2010) | Blease Medical Equipment, Ltd. | 2010-04-16 |