The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for Stat-shell Disposable Sp02 Sensor.
| Device ID | K000831 |
| 510k Number | K000831 |
| Device Name: | STAT-SHELL DISPOSABLE SP02 SENSOR |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-14 |
| Decision Date | 2000-06-05 |