Alphaone Biofeedback System
FDA 510(k) K071661 · Telediagnostic Systems, Inc.
510(k) numberK071661
Submission
- Device name
- Alphaone Biofeedback System
- Applicant
- Telediagnostic Systems, Inc.
Mountain View, CA, US - Received
- June 19, 2007
- Decision date
- September 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Alphaone Biofeedback System cleared by the FDA?
Alphaone Biofeedback System (K071661) received a 510(k) decision of Substantially Equivalent on September 5, 2007, 78 days after the submission was received.
What is the product code of K071661?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.