COMPONENT NEUROMONITORING SYSTEM
FDA 510(k) clearance K080217 · decided 2008-11-05
Clearance details
- K-number
- K080217
- Device name
- COMPONENT NEUROMONITORING SYSTEM
- Applicant
- Moberg Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-29
- Decision date
- 2008-11-05
- Days to decision
- 281 days
- Clearance type
- Traditional
- Product code
- OMA
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Ambler, PA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurologica recall (Z-1338-2023) | Moberg Research, Inc. | 2023-04-04 |