NIM 3.0
FDA 510(k) clearance K083124 · decided 2009-02-27
Clearance details
- K-number
- K083124
- Device name
- NIM 3.0
- Applicant
- Medtronic Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-22
- Decision date
- 2009-02-27
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- GWF
- Device class
- 2
- Regulation number
- 882.1870
- 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 |
|---|---|---|
| Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfac recall (Z-2342-2012) | Medtronic Xomed, Inc. | 2012-09-10 |
| Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfac recall (Z-2343-2012) | Medtronic Xomed, Inc. | 2012-09-10 |
| Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfac recall (Z-2344-2012) | Medtronic Xomed, Inc. | 2012-09-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S009) | Medtronic Xomed, Inc. | 1999-07-16 |
| LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S008) | Medtronic Xomed, Inc. | 1999-07-09 |
| LAMICEL(R) OSMOSTIC CERVICAL DILATOR (P820075/S007) | Medtronic Xomed, Inc. | 1996-01-03 |
| LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S006) | Medtronic Xomed, Inc. | 1995-10-10 |
| LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S005) | Medtronic Xomed, Inc. | 1991-10-09 |
| LAMICEL(TM) (P820075/S004) | Medtronic Xomed, Inc. | 1988-05-24 |
| LAMICEL(TM) (P820075/S002) | Medtronic Xomed, Inc. | 1986-08-22 |
| LAMICEL(TM) (P820075/S001) | Medtronic Xomed, Inc. | 1985-02-12 |