FlexiMarc Marker
510(k) K142294
FlexiMarc Marker is a Class II device made by Cortex Manufacturing Inc., cleared under FDA 510(k) K142294 on 26 Mar 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142294 | Date26 Mar 2015 | StatusActive |
Official records
- FDA 510(k) database K142294
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- FDA applicant
- Cortex Manufacturing, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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