510(k) K934050

TOPOGRAPHIC BRAIN MAPPING OPTION by Biosound, Inc. — Product Code OLT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 3, 1994
Date Received: August 19, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Normalizing Quantitative Electroencephalograph Software
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

Other clearances by Biosound, Inc.

K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER (July 9, 1997)
K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER (March 31, 1997)
K963262 — ARTOSCAN M (March 28, 1997)
K963662 — GALILEO EVOKED POTENTIALRE (February 26, 1997)
K953716 — INTRACAVITY TRANSDUCERS (April 17, 1996)
K953530 — DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A (April 8, 1996)
K953819 — DIAGNOSTIC ULTRASOUND TRANDUCER (March 1, 1996)
K953759 — DIAGNOSTIC ULTRASOUND TRANSDUCER (March 1, 1996)
K955458 — ULTRASOUND PROBE BIOPSY ACCESSORIES (February 12, 1996)
K953579 — TEE PROBE (February 2, 1996)

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