The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for E100a Pulse Oximeter Finger Sensor/probe.
| Device ID | K954168 |
| 510k Number | K954168 |
| Device Name: | E100A PULSE OXIMETER FINGER SENSOR/PROBE |
| Classification | Oximeter |
| Applicant | EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE Dallas, TX 75248 |
| Contact | Kenneth F Perdue |
| Correspondent | Kenneth F Perdue EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE Dallas, TX 75248 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1996-09-12 |