Porti 7 Physiological Amplifier
FDA 510(k) K063599 · Tms International BV
510(k) numberK063599
Submission
- Device name
- Porti 7 Physiological Amplifier
- Applicant
- Tms International BV
Evergreen, CO, US - Received
- December 4, 2006
- Decision date
- March 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GWL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243746 | Delphi AmplifierGWL · Traditional | Quantalx Neroscience | 03/12/2025SE |
| K242832 | NExT Station; NExT Station AdvancedGWL · Special | Eb Neuro S.P.A. | 12/12/2024SE |
| K242305 | BE Plus PRO, Neurotravel LIGHTGWL · Special | Eb Neuro S.P.A. | 09/04/2024SE |
| K240646 | DreamClearGWL · Traditional | Somnomed Technologies Inc., Doing Business AS… | 09/04/2024SE |
| K232210 | X-trodes System MGWL · Traditional | X-Trodes | 02/04/2024SE |
| K230148 | VlabGWL · Traditional | Dormotech Medical, Ltd. | 10/11/2023SE |
| K223676 | SomniCheckGWL · Traditional | Brainmatterz, LLC | 06/01/2023SE |
| K220631 | NomadAir PMU810GWL · Traditional | Neurotronics, Inc. | 07/15/2022SE |
| K203331 | Quick-20mGWL · Traditional | Cgx, LLC | 05/20/2021SE |
| K202174 | Digital NeuroPort Biopotential Signal Processing SystemGWL · Special | Blackrock Microsystems | 02/10/2021SE |
More from Blackrock Microsystems
| 510(k) | Device | Decision |
|---|---|---|
| K060374 | Refa, Physiological AmplifierGWL · Abbreviated | 05/30/2006SE |
Questions and answers
When was Porti 7 Physiological Amplifier cleared by the FDA?
Porti 7 Physiological Amplifier (K063599) received a 510(k) decision of Substantially Equivalent on March 22, 2007, 108 days after the submission was received.
What is the product code of K063599?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.