The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for Epic Spo2 Finger Sensor, Model E403-09, E412-09 And Epic Oximeter Cable, Model E710-09.
| Device ID | K990082 |
| 510k Number | K990082 |
| Device Name: | EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 |
| Classification | Oximeter |
| Applicant | EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano, TX 75074 |
| Contact | Jeffrey Secunda |
| Correspondent | Jeffrey Secunda EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano, TX 75074 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-11 |
| Decision Date | 1999-04-09 |
| Summary: | summary |