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About Argos 510K
The document provides notification that the FDA has reviewed Santec Corporation's Section 510(k) submission for their Argos device and determined it to be substantially equivalent to legally marketed predicate devices. The FDA clearance allows Santec to market the Argos device, which is an optical biometer intended to acquire ocular measurements to determine appropriate intraocular lens power and type for cataract surgery. The letter details regulatory requirements and provides enclosure of indications for use stating the Argos device capabilities.
Detailed Information
| Author: | ['Norman Guntson'] |
|---|---|
| Publication Year: | 2020 |
| Pages: | 10 |
| Language: | English |
| Format: | |
| Price: | FREE |
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