ACTIVE ELECTRODE MONITORING SYSTEM
FDA 510(k) clearance K000480 · decided 2000-05-02
Clearance details
- K-number
- K000480
- Device name
- ACTIVE ELECTRODE MONITORING SYSTEM
- Applicant
- Electroscope, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-14
- Decision date
- 2000-05-02
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Indian Hills, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EM2 NC AEM Monitor (NON-COM) recall (Z-1050-03) | Encision, Inc. | 2003-07-24 |
| EM2+A NC AEM Monotor (NON-COM) recall (Z-1051-03) | Encision, Inc. | 2003-07-24 |
| EM2M NC AEM Monitor, (NON-COM) recall (Z-1052-03) | Encision, Inc. | 2003-07-24 |