The Mirage System Biofeedback Interface
FDA 510(k) K941938 · Intercare Diagnostics, Inc.
510(k) numberK941938
Submission
- Device name
- The Mirage System Biofeedback Interface
- Applicant
- Intercare Diagnostics, Inc.
Inglewood, CA, US - Received
- April 21, 1994
- Decision date
- August 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was The Mirage System Biofeedback Interface cleared by the FDA?
The Mirage System Biofeedback Interface (K941938) received a 510(k) decision of Substantially Equivalent on August 5, 1994, 106 days after the submission was received.
What is the product code of K941938?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.