BioWaveGO— 510(k) K180943
Substantially EquivalentBiowave Corporation
FDA 510(k) clearance K180943 for BioWaveGO, Substantially Equivalent on 2018-08-17. Applicant: Biowave Corporation. Device class: 2.
Clearance details
- Applicant
- Biowave Corporation
- 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
- Norwalk, CT, US
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