FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K Number: K210484
·
Decision Jun 11, 2021
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
32
Applicant Total
209
Review Days
112
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Basic Information
- Device Name
- LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
- K Number
- K210484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- February 19, 2021
- Decision Date
- June 11, 2021
- 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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