Be Plus LTM Amplifier Gwi Amplifier
FDA 510(k) K121996 · Eb Neuro S.P.A.
510(k) numberK121996
Submission
- Device name
- Be Plus LTM Amplifier Gwi Amplifier
- Applicant
- Eb Neuro S.P.A.
Indianapolis, IN, US - Received
- July 9, 2012
- Decision date
- August 3, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Blackrock Microsystems
| 510(k) | Device | Decision |
|---|---|---|
| K242832 | NExT Station; NExT Station AdvancedGWL · Special | 12/12/2024SE |
| K242305 | BE Plus PRO, Neurotravel LIGHTGWL · Special | 09/04/2024SE |
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-FastGWF · Traditional | 08/19/2015SE |
| K142064 | Galileo NTOLT · Traditional | 02/13/2015SE |
| K133517 | Nemus 2 SystemGWL · Traditional | 02/26/2014SE |
| K093728 | Be Micro, TreaOLV · Traditional | 04/29/2010SE |
| K073415 | Nemus System; Nemus PC PeripheralIKN · Traditional | 05/23/2008SE |
| K061996 | Sandman PocketMNR · Traditional | 10/03/2006SE |
| K053606 | Be Plus / AURA-LTM64 AmplifierGWL · Special | 01/24/2006SE |
| K041198 | NIC36 AmplifierGWL · Special | 06/01/2004SE |
Questions and answers
When was Be Plus LTM Amplifier Gwi Amplifier cleared by the FDA?
Be Plus LTM Amplifier Gwi Amplifier (K121996) received a 510(k) decision of Substantially Equivalent on August 3, 2012, 25 days after the submission was received.
What is the product code of K121996?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.