BioWave BioWraps— 510(k) K203158
Substantially EquivalentBiowave Corporation
FDA 510(k) clearance K203158 for BioWave BioWraps, Substantially Equivalent on 2021-07-08. Applicant: Biowave Corporation. Device class: 2.
Clearance details
- Applicant
- Biowave Corporation
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwalk, CT, US
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More clearances from Biowave Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.