Grass TS3201/6401 EEG Amplifier System
FDA 510(k) K994142 · Grass Instrument Co.
510(k) numberK994142
Submission
- Device name
- Grass TS3201/6401 EEG Amplifier System
- Applicant
- Grass Instrument Co.
Braintree, MA, US - Received
- December 8, 1999
- Decision date
- March 6, 2000
- 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 Grass TS3201/6401 EEG Amplifier System cleared by the FDA?
Grass TS3201/6401 EEG Amplifier System (K994142) received a 510(k) decision of Substantially Equivalent on March 6, 2000, 89 days after the submission was received.
What is the product code of K994142?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.