Professional Series Biofeedback Devices Model 421
FDA 510(k) K875308 · Self Regulation Systems, Inc.
510(k) numberK875308
Submission
- Device name
- Professional Series Biofeedback Devices Model 421
- Applicant
- Self Regulation Systems, Inc.
Redmond, WA, US - Received
- December 29, 1987
- Decision date
- February 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Professional Series Biofeedback Devices Model 421 cleared by the FDA?
Professional Series Biofeedback Devices Model 421 (K875308) received a 510(k) decision of Substantially Equivalent on February 26, 1988, 59 days after the submission was received.
What is the product code of K875308?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.