FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
K Number: K193473
·
Decision Jun 26, 2020
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
32
Applicant Total
231
Review Days
193
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Basic Information
- Device Name
- LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
- K Number
- K193473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- December 16, 2019
- Decision Date
- June 26, 2020
- Product Code
- MXD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | FDA class 2 | Cardiovascular |
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