Opti-Amp Dc-Powered
FDA 510(k) K052060 · Intelligent Hearing Systems
510(k) numberK052060
Submission
- Device name
- Opti-Amp Dc-Powered
- Applicant
- Intelligent Hearing Systems
Miami, FL, US - Received
- July 29, 2005
- Decision date
- August 31, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Opti-Amp Dc-Powered cleared by the FDA?
Opti-Amp Dc-Powered (K052060) received a 510(k) decision of Substantially Equivalent on August 31, 2005, 33 days after the submission was received.
What is the product code of K052060?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.