PRIMA ANAESTHESIA MACHINE
FDA 510(k) clearance K061102 · decided 2006-07-28
Clearance details
- K-number
- K061102
- Device name
- PRIMA ANAESTHESIA MACHINE
- Applicant
- Penlon , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-19
- Decision date
- 2006-07-28
- Days to decision
- 100 days
- Clearance type
- Special
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Barton Lane, Abingdon, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device u recall (Z-1318-2012) | Penlon, Ltd. | 2012-03-26 |