Duo-Tel
FDA 510(k) K810331 · General Electric Co.
510(k) numberK810331
Submission
- Device name
- Duo-Tel
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- February 9, 1981
- Decision date
- March 20, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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Questions and answers
When was Duo-Tel cleared by the FDA?
Duo-Tel (K810331) received a 510(k) decision of Substantially Equivalent on March 20, 1981, 39 days after the submission was received.
What is the product code of K810331?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.