BioWaveGO RX
FDA 510(k) clearance K210202 · decided 2021-02-24
Clearance details
- K-number
- K210202
- Device name
- BioWaveGO RX
- Applicant
- Biowave Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-01-25
- Decision date
- 2021-02-24
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.