LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System— 510(k) K210484
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K210484 for LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System, Substantially Equivalent on 2021-06-11. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code MXD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mounds View, MN, US
Recent devices under product code MXD
view all- K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
- K261074 — BIOMONITOR IV (471155)
- K253516 — Assert-IQ (DM5100)
- K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
- K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
More clearances from Medtronic, Inc.
view allAdverse events under product code MXD
product code MXD- Injury
- 1,880
- Malfunction
- 9,487
- Total
- 11,367
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.