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FDA 510(k)

THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE

K-Number: K941938 · 1994-08-05

ApplicantIntercare Diagnostics, Inc.
Decision Date1994-08-05
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is Intercare Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K941938. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE?

THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Intercare Diagnostics, Inc.. The 510(k) number is K941938.

When did THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE receive FDA 510(k) clearance?

THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE received FDA 510(k) clearance on 1994-08-05, under 510(k) number K941938.

Who is the listed applicant for THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE?

The FDA 510(k) record lists Intercare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE?

The FDA product code for THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE is HCC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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