The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Poet Oximeter.
| Device ID | K864745 |
| 510k Number | K864745 |
| Device Name: | POET OXIMETER |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Contact | Der Ruhr |
| Correspondent | Der Ruhr CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-05 |
| Decision Date | 1987-06-02 |