Sc/Temp 300
510(k) K810332
Sc/Temp 300 is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K810332 on 18 May 1981, 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 | NumberK810332 | Date18 May 1981 | StatusActive |
Official records
- FDA 510(k) database K810332
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HCC
- FDA applicant
- Thought Technology , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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