ACCUGUIDE MUSCLE INJECTION MONITOR
FDA 510(k) clearance K990793 · decided 1999-10-22
Clearance details
- K-number
- K990793
- Device name
- ACCUGUIDE MUSCLE INJECTION MONITOR
- Applicant
- Medtronic Xomed
- Decision
- Substantially Equivalent
- Date received
- 1999-03-10
- Decision date
- 1999-10-22
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- GXZ
- Device class
- 2
- Regulation number
- 882.1350
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, produ recall (Z-0576-2007) | Medtronic Xomed, Inc. | 2007-03-07 |