UNIVERSAL XACTTRACE— 510(k) K043132
Substantially EquivalentMedcare Flaga
FDA 510(k) clearance K043132 for UNIVERSAL XACTTRACE, Substantially Equivalent on 2004-12-21. Applicant: Medcare Flaga. Device class: 2.
Clearance details
- Applicant
- Medcare Flaga
- 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
- Reykjavik, IS
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