Opti-Amp
by Intelligent Hearing Systems
510(k) K914876
Opti-Amp is a medical device (FDA Class II; FDA product code GWL, Amplifier, Physiological Signal) made by Intelligent Hearing Systems, cleared under FDA 510(k) K914876 on 10 Jan 1992, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914876 | Date10 Jan 1992 | StatusActive |
Official records
- FDA 510(k) database K914876
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWL
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1835
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K914876
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OPTI-AMP USB Box M012300 | M012300 | 00817020020440 | — | On the market |
Similar devices
Other devices filed under FDA product code GWL (Amplifier, Physiological Signal).
- AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) by Amplaid USA, Inc.
- NeMus 2 System by EB Neuro S.p.A.
- Delphi Amplifier by Quantalx Neroscience
- VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER by Telediagnostic Systems, Inc.
- NExT Station; NExT Station Advanced by EB Neuro S.p.A.
- MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER by NIHON KOHDEN AMERICA, INC.
- Vlab by Dormotech Medical, Ltd.
- AM-PAK by Cns, Inc.
- R-40 EEG Amplifier by Lifelines Ltd.
- PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER by Professional Health Technologies, Inc.