XPS NITRO SYSTEM
FDA 510(k) clearance K002828 · decided 2000-10-17
Clearance details
- K-number
- K002828
- Device name
- XPS NITRO SYSTEM
- Applicant
- Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-11
- Decision date
- 2000-10-17
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, recall (Z-0259-2010) | Medtronic Xomed, Inc. | 2009-11-13 |