POLESTAR N-10
FDA 510(k) clearance K010850 · decided 2001-12-17
Clearance details
- K-number
- K010850
- Device name
- POLESTAR N-10
- Applicant
- Odin Medical Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-21
- Decision date
- 2001-12-17
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Yokneam Elit, IL
- 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 |