The following data is part of a premarket notification filed by L.d. Technology, Llc with the FDA for E.s.o. (electro Sensor Oxi).
| Device ID | K102442 |
| 510k Number | K102442 |
| Device Name: | E.S.O. (ELECTRO SENSOR OXI) |
| Classification | Oximeter |
| Applicant | L.D. TECHNOLOGY, LLC 100 N. BISCAYNE BLVD SUITE 500 Miami, FL 33132 |
| Contact | Albert Maarek |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-26 |
| Decision Date | 2010-09-10 |
| Summary: | summary |