Recall Z-0526-2013— EEG Info
Class II · Terminated
Class II FDA medical device recall by EEG Info, initiated 2012-11-15, terminated 2013-06-11. It names one FDA 510(k) clearance: K073557. Product: EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation. Reason: EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices..
- Recalling firm
- EEG Info
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-15
- Terminated
- 2013-06-11
- Firm location
- Woodland Hills, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Reason for recall
EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.