AURIS AEP— 510(k) K012415
Substantially EquivalentSynapsys, Inc.
FDA 510(k) clearance K012415 for AURIS AEP, Substantially Equivalent on 2001-12-18. Applicant: Synapsys, Inc.. Device class: 2.
Clearance details
- Applicant
- Synapsys, Inc.
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jamaica, NY, US
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