AFIBALERT ATRIAL FIBRILLATION DETECTOR— 510(k) K052767
Substantially EquivalentLechnologies Research, Inc.
FDA 510(k) clearance K052767 for AFIBALERT ATRIAL FIBRILLATION DETECTOR, Substantially Equivalent on 2006-06-23. Applicant: Lechnologies Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Lechnologies Research, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sussex, WI, US
Recent devices under product code DXH
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