Opti-Amp Dc-Powered
by Intelligent Hearing Systems
510(k) K052060
Opti-Amp Dc-Powered is a medical device (FDA Class II; FDA product code GWL, Amplifier, Physiological Signal) made by Intelligent Hearing Systems, cleared under FDA 510(k) K052060 on 31 Aug 2005, active as of 9 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 | NumberK052060 | Date31 Aug 2005 | StatusActive |
Official records
- FDA 510(k) database K052060
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- Withdrawn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 K052060
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.
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