510(k) K171397
- Device
- Sienna Ultimate Wireless Amplifier
- Applicant
- EMS Handels Gesellschaft M.b.H.
- 510(k) number
- K171397
- Product code
- GWL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-06
- Date received
- 2017-05-11
- Regulation
- 882.1835
- Classification name
- Amplifier, Physiological Signal
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ruzena Ortnerova
- Address
- Jochingergasse 1 Korneuburg AT A-2100 A-2100
FDA Registration Numbers#
- 3010762896
- 3010611950
- 3007701713
- 3005713796
- 9612389
- 1063925
- 3015491430
- 3007323246
- 3038274470
- 3005581270
- 1721676
- 3015614098
- 3025186177
- 9617286
- 3038138206
- 1052723
- 3011782009
- 3038185755
- 3001687738
- 3016939722
- 9710486
- 3008008477
- 3008773490
- 3020018
- 3004883754
Source Documents#
Other 510(k) Records For Product Code GWL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243746 | Delphi Amplifier | Quantalx Neroscience | 2025-03-12 |
| K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | 2024-12-12 |
| K242305 | BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. | 2024-09-04 |
| K240646 | DreamClear | Somnomed Technologies Inc., Doing Business AS Remware | 2024-09-04 |
| K232210 | X-trodes System M | X-Trodes | 2024-02-04 |
| 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 |
| K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017-07-05 |
| K151600 | R-40 EEG Amplifier | Lifelines , Ltd. | 2015-10-23 |
| K133517 | NEMUS 2 SYSTEM | Eb Neuro S.P.A. | 2014-02-26 |
Legacy Summary#
summary
FDA Review#
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