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510(k) K941938

THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE by Intercare Diagnostics, Inc. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
April 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Intercare Diagnostics, Inc.

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  • K901597 — INDX DIP S TICKS (December 21, 1990)
  • K893895 — HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL (July 25, 1989)
  • K862948 — CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) (October 17, 1986)

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