The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for Flexi-site (e203-01)/ Flexi-fit (e300).
| Device ID | K964055 |
| 510k Number | K964055 |
| Device Name: | FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) |
| Classification | Oximeter |
| Applicant | EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE Dallas, TX 75248 |
| Contact | Jeffrey Secunda |
| Correspondent | Jeffrey Secunda 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 | 1996-10-09 |
| Decision Date | 1997-02-21 |