PeriFlux6000— 510(k) K152930
Substantially EquivalentPerimed AB
FDA 510(k) clearance K152930 for PeriFlux6000, Substantially Equivalent on 2016-05-05. Applicant: Perimed AB. Device class: 2.
Clearance details
- Applicant
- Perimed AB
- Product code
- Code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jarfalla, SE
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