Teratech, Model 2000 Imaging Imaging
510(k) K992505
Teratech, Model 2000 Imaging is a medical device (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Teratech Corp., cleared under FDA 510(k) K992505 on 10 Nov 1999, 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 | NumberK992505 | Date10 Nov 1999 | StatusActive |
Official records
- FDA 510(k) database K992505
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYO
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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