TRUWAVE— 510(k) K013210
Substantially EquivalentDan Med, Inc.
FDA 510(k) clearance K013210 for TRUWAVE, Substantially Equivalent on 2002-04-04. Applicant: Dan Med, Inc.. Device class: 2.
Clearance details
- Applicant
- Dan Med, Inc.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denver, CO, US
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