510(k) K905372

MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 by Bio-Feedback Systems, Inc. — Product Code HCC

K905372 is an FDA 510(k) premarket notification submitted by Bio-Feedback Systems, Inc. for the device "MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002". The FDA issued a decision of Substantially Equivalent on April 12, 1991. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Bio-Feedback Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
November 29, 1990
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