K102442 is an FDA 510(k) clearance for the E.S.O. (ELECTRO SENSOR OXI). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on September 10, 2010, 15 days after receiving the submission on August 26, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K102442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2010 |
| Decision Date | September 10, 2010 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |