HARMONE-SCHWARZER EEG SYSTEM
FDA 510(k) clearance K010728 · decided 2001-05-21
Clearance details
- K-number
- K010728
- Device name
- HARMONE-SCHWARZER EEG SYSTEM
- Applicant
- Stellate Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-03-12
- Decision date
- 2001-05-21
- Days to decision
- 70 days
- Clearance type
- Abbreviated
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Westmount, Quebec, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models recall (Z-1080-2013) | Stellate Systems | 2013-04-22 |