Bis Quatro Sensor
FDA 510(k) K093183 · Aspect Medical Systems, Inc.
510(k) numberK093183
Submission
- Device name
- Bis Quatro Sensor
- Applicant
- Aspect Medical Systems, Inc.
Norwood, MA, US - Received
- October 9, 2009
- Decision date
- October 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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More from Bionit Labs Srl
| 510(k) | Device | Decision |
|---|---|---|
| K091854 | Bis Click Sensor/CableGXY · Traditional | 07/02/2009SE |
| K072286 | Bis EEG Vista Monitor System and BisxOLW · Traditional | 11/20/2007SE |
| K062613 | Bis EEG Monitor ViewOLW · Special | 06/18/2007SE |
| K070069 | Zipprep ElectrodeGXY · Special | 02/05/2007SE |
| K062692 | Bis Bilateral SensorGXY · Special | 12/13/2006SE |
| K052981 | Bis EEG Monitor, Model BISX4OLW · Special | 11/01/2005SE |
| K052362 | Bis EEG Monitor, Model A-3000OLW · Special | 09/09/2005SE |
| K050313 | Bis SRS (Semi-Resuable Sensor)GWY · Traditional | 02/24/2005SE |
| K041670 | Bis Pediatric SensorGXY · Special | 07/06/2004SE |
| K040183 | BisxOLW · Special | 02/25/2004SE |
Questions and answers
When was Bis Quatro Sensor cleared by the FDA?
Bis Quatro Sensor (K093183) received a 510(k) decision of Substantially Equivalent on October 23, 2009, 14 days after the submission was received.
What is the product code of K093183?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.