510(k) K090957
- Device
- BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
- Applicant
- I2S MICRO IMPLANTABLE SYSTEMS, LLC
- 510(k) number
- K090957
- Product code
- GWL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-28
- Date received
- 2009-04-06
- Regulation
- 882.1835
- Classification name
- Amplifier, Physiological Signal
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gary Syring
- Address
- 800 Levanger Ln. Stoughton WI US 53589 53589
FDA Registration Numbers#
- 1721676
- 9617286
- 3015491430
- 9612389
- 1052723
- 3038138206
- 3005713796
- 3038185755
- 3008008477
- 1063925
- 3001687738
- 3011782009
- 3010611950
- 3004883754
- 3007323246
- 9710486
- 3025186177
- 3007701713
- 3020018
- 3005581270
- 3010762896
- 3038274470
- 3008773490
- 3015614098
- 3016939722
Source Documents#
Other 510(k) Records For Product Code GWL #
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| K230148 | Vlab | Dormotech Medical, Ltd. | 2023-10-11 |
| K223676 | SomniCheck | Brainmatterz, LLC | 2023-06-01 |
| K220631 | NomadAir PMU810 | Neurotronics, Inc. | 2022-07-15 |
| K203331 | Quick-20m | Cgx, LLC | 2021-05-20 |
| K202174 | Digital NeuroPort Biopotential Signal Processing System | Blackrock Microsystems | 2021-02-10 |
| K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | 2020-12-27 |
| K172312 | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | 2018-03-30 |
| K171397 | Sienna Ultimate Wireless Amplifier | Ems Handels Gesellschaft M.B.H. | 2017-10-06 |
| K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017-07-05 |
| K151600 | R-40 EEG Amplifier | Lifelines , Ltd. | 2015-10-23 |
Legacy Summary#
summary
FDA Review#
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