Be Micro, Trea
FDA 510(k) K093728 · Eb Neuro S.P.A.
510(k) numberK093728
Submission
- Device name
- Be Micro, Trea
- Applicant
- Eb Neuro S.P.A.
Carmel, IN, US - Received
- December 3, 2009
- Decision date
- April 29, 2010
- 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 Be Micro, Trea cleared by the FDA?
Be Micro, Trea (K093728) received a 510(k) decision of Substantially Equivalent on April 29, 2010, 147 days after the submission was received.
What is the product code of K093728?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.