TEA Device— 510(k) K230526
Substantially EquivalentTranstimulation Research, Inc.
FDA 510(k) clearance K230526 for TEA Device, Substantially Equivalent on 2023-09-14. Applicant: Transtimulation Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Transtimulation Research, Inc.
- Product code
- Code QHH
- Device class
- Class 2
- Regulation
- 21 CFR 876.5340
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oklahoma City, OK, US
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