510(k) K771023

ANALOG QUANTIFIER MODEL AQ-100 by Bio-Feedback Systems, Inc. — Product Code HCC

K771023 is an FDA 510(k) premarket notification submitted by Bio-Feedback Systems, Inc. for the device "ANALOG QUANTIFIER MODEL AQ-100". The FDA issued a decision of Substantially Equivalent on June 24, 1977. 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
June 24, 1977
Date Received
June 8, 1977
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