| Device Type ID | 3643 |
| Device Name | Amplifier, Physiological Signal |
| Regulation Description | Physiological Signal Amplifier. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1835 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GWL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3643 |
| Device | Amplifier, Physiological Signal |
| Product Code | GWL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Physiological Signal Amplifier. |
| CFR Regulation Number | 882.1835 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EB NEURO, S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EMS HANDELS GESELLSCHAFT M.B.H. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFELINES LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Blackrock Microsystems, LLC | II | Sep-08-2016 |