The following data is part of a premarket notification filed by Oximetrix, Inc. with the FDA for Opticath.
| Device ID | K820674 |
| 510k Number | K820674 |
| Device Name: | OPTICATH |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | OXIMETRIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-11 |
| Decision Date | 1982-03-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OPTICATH 73154721 1119970 Live/Registered |
OXIMETRIX, INC. 1978-01-09 |