BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM— 510(k) K090957
Substantially EquivalentI2s Micro Implantable Systems, LLC
FDA 510(k) clearance K090957 for BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM, Substantially Equivalent on 2009-05-28. Applicant: I2s Micro Implantable Systems, LLC. Device class: 2.
Clearance details
- Applicant
- I2s Micro Implantable Systems, LLC
- Product code
- Code GWL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1835
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Stoughton, WI, US
Recent devices under product code GWL
view allRecalls naming K090957
K-number listed on FDA's recall record- Z-2763-2016 — Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
- Z-2764-2016 — Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090957.
Data sourced from openFDA. This site is unofficial and independent of the FDA.