Rubicon SA System— 510(k) K200654
Substantially EquivalentDymedix Diagnostics, Inc.
FDA 510(k) clearance K200654 for Rubicon SA System, Substantially Equivalent on 2020-07-22. Applicant: Dymedix Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Dymedix Diagnostics, Inc.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shoreview, MN, US
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