Cadwell Flex Eeg/Psg
FDA 510(k) K133355 · Cadwell Industries, Inc.
510(k) numberK133355
Submission
- Device name
- Cadwell Flex Eeg/Psg
- Applicant
- Cadwell Industries, Inc.
Kennewick, WA, US - Received
- October 31, 2013
- Decision date
- January 29, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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Questions and answers
When was Cadwell Flex Eeg/Psg cleared by the FDA?
Cadwell Flex Eeg/Psg (K133355) received a 510(k) decision of Substantially Equivalent on January 29, 2014, 90 days after the submission was received.
What is the product code of K133355?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.