Topographic Brain Mapping Option
FDA 510(k) K934050 · Biosound, Inc.
510(k) numberK934050
Submission
- Device name
- Topographic Brain Mapping Option
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- August 19, 1993
- Decision date
- February 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OLT – Non-Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
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Questions and answers
When was Topographic Brain Mapping Option cleared by the FDA?
Topographic Brain Mapping Option (K934050) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 168 days after the submission was received.
What is the product code of K934050?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.