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 |