Frontier X Plus
FDA 510(k) clearance K240794 · decided 2024-11-08
Clearance details
- K-number
- K240794
- Device name
- Frontier X Plus
- Applicant
- Fourth Frontier Technologies Pvt, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-22
- Decision date
- 2024-11-08
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- MLO
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bengaluru, IN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fourth Frontier Technologies Pvt
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.