Amplifier, Physiological Signal
Regulation 882.1835
0510(k)s in 12 months (53 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in GWL
| Company | 510(k)s | Recalls |
|---|---|---|
| Eb Neuro S.P.A. | 8 | 0 |
| Blackrock Microsystems | 1 | 2 |
| G.Tec Medical Engineering GmbH | 3 | 0 |
| Nihon Kohden America, Inc. | 3 | 0 |
| Honeywell, Inc. | 2 | 0 |
| I2s Micro Implantable Systems, LLC | 1 | 1 |
| Intelligent Hearing Systems | 2 | 0 |
| Neurotronics, Inc. | 2 | 0 |
| Tms International BV | 2 | 0 |
| Allergan, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2016 | Blackrock Microsystems, LLC Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons.
Product Usage:
The Blackrock NeuroPort Biopotential Signal Processing System supports recording, pr Terminated |
GWL | K090957 |
| Sep 8, 2016 | Blackrock Microsystems, LLC 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 biopote Terminated |
GWL | K090957 |
| Mar 13, 2013 | Natus Neurology Incorporated Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier.
Product Usage:
The Nicolet Wireless EEG Ampli Terminated |
GWL | K103140 |
| May 20, 2010 | I2s Micro Implantable Systems Llc Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT.
Intended use: The Inserter Wa Terminated |
GWL | K042384 |
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