Flaatz 750
by Drtech Corp.
510(k) K080064
Flaatz 750 is a Class II device made by Drtech Corp., cleared under FDA 510(k) K080064 on 23 Jan 2008, 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 | NumberK080064 | Date23 Jan 2008 | StatusActive |
Official records
- FDA 510(k) database K080064
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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