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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 1978 | K781289 | PREAMPLIFIER MODEL 113 Princeton Applied Research Corp. | GWL |
| Nov 21, 1977 | K772102 | AMPLIFIER OTRONA, MODEL N3A-EMG Honeywell, Inc. | GWL |
| Sep 20, 1977 | K771683 | AMPLIFIER MODEL N3B-EEG Honeywell, Inc. | GWL |
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