Cadwell Bolt Software
FDA 510(k) K190760 · Cadwell Industries, Inc.
510(k) numberK190760
Submission
- Device name
- Cadwell Bolt Software
- Applicant
- Cadwell Industries, Inc.
Kennewick, WA, US - Received
- March 25, 2019
- Decision date
- November 23, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Cadwell Bolt Software cleared by the FDA?
Cadwell Bolt Software (K190760) received a 510(k) decision of Substantially Equivalent on November 23, 2019, 243 days after the submission was received.
What is the product code of K190760?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.