ENFANTTM
FDA 510(k) clearance K043491 · decided 2005-03-16
Clearance details
- K-number
- K043491
- Device name
- ENFANTTM
- Applicant
- Diopsys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-17
- Decision date
- 2005-03-16
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- GWE
- Device class
- 2
- Regulation number
- 882.1890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pine Brook, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
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|---|---|---|
| Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60 recall (Z-1437-2010) | Diopsys, Inc. | 2010-04-26 |