Ablamap Software
by Ablacon Inc.
510(k) K203084
Ablamap Software is a Class II device made by Ablacon Inc., cleared under FDA 510(k) K203084 on 31 Aug 2021, 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 | NumberK203084 | Date31 Aug 2021 | StatusActive |
Official records
- FDA 510(k) database K203084
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- FDA applicant
- Ablacon, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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