Wireless Input Unit, Model WEE-1000A Series
FDA 510(k) K033475 · Nihon Kohden America, Inc.
510(k) numberK033475
Submission
- Device name
- Wireless Input Unit, Model WEE-1000A Series
- Applicant
- Nihon Kohden America, Inc.
Foothill, CA, US - Received
- November 3, 2003
- Decision date
- January 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
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Questions and answers
When was Wireless Input Unit, Model WEE-1000A Series cleared by the FDA?
Wireless Input Unit, Model WEE-1000A Series (K033475) received a 510(k) decision of Substantially Equivalent on January 7, 2004, 65 days after the submission was received.
What is the product code of K033475?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.