K172492 is an FDA 510(k) clearance for the Optical Topography System ETG-4100. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Hitachi Healthcare Americas (Twinsburg, US). The FDA issued a Cleared decision on August 17, 2018, 365 days after receiving the submission on August 17, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K172492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2017 |
| Decision Date | August 17, 2018 |
| Days to Decision | 365 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |