Smart One— 510(k) K181666
Substantially EquivalentMir Medical International Research
FDA 510(k) clearance K181666 for Smart One, Substantially Equivalent on 2018-08-01. Applicant: Mir Medical International Research. Device class: 2.
Clearance details
- Applicant
- Mir Medical International Research
- Product code
- Code BZH
- Device class
- Class 2
- Regulation
- 21 CFR 868.1860
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roma, IT
Recent devices under product code BZH
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