Ultramind Biofeedback System with De-Stress Software
FDA 510(k) K980373 · Ultramind International , Ltd.
510(k) numberK980373
Submission
- Device name
- Ultramind Biofeedback System with De-Stress Software
- Applicant
- Ultramind International , Ltd.
Ra'Ananna 43373, IL - Received
- January 30, 1998
- Decision date
- April 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ultramind Biofeedback System with De-Stress Software cleared by the FDA?
Ultramind Biofeedback System with De-Stress Software (K980373) received a 510(k) decision of Substantially Equivalent on April 29, 1998, 89 days after the submission was received.
What is the product code of K980373?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.