The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for Flexi-site Sp02 Ear Sensor.
| Device ID | K010718 |
| 510k Number | K010718 |
| Device Name: | FLEXI-SITE SP02 EAR SENSOR |
| Classification | Oximeter, Ear |
| Applicant | EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano, TX 75074 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano, TX 75074 |
| Product Code | DPZ |
| CFR Regulation Number | 870.2710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2001-03-23 |