The following data is part of a premarket notification filed by Elekon Industries U.s.a., Inc. with the FDA for Flexi-stat Sp02 Ear Sensor.
| Device ID | K042675 |
| 510k Number | K042675 |
| Device Name: | FLEXI-STAT SP02 EAR SENSOR |
| Classification | Oximeter, Ear |
| Applicant | ELEKON INDUSTRIES U.S.A., INC. 2300 MCDERMOTT RD. #200-207 Plano, TX 75025 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes ELEKON INDUSTRIES U.S.A., INC. 2300 MCDERMOTT RD. #200-207 Plano, TX 75025 |
| Product Code | DPZ |
| CFR Regulation Number | 870.2710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2004-12-06 |
| Summary: | summary |