Jot Dx Insertable Cardiac Monitor
FDA 510(k) clearance K212206 · decided 2021-08-13
Clearance details
- K-number
- K212206
- Device name
- Jot Dx Insertable Cardiac Monitor
- Applicant
- Abbott (St. Jude Medical)
- Decision
- Substantially Equivalent
- Date received
- 2021-07-15
- Decision date
- 2021-08-13
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MXC
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.