The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Edslab(r) Dual Lumen Region Satur Oximetry Cath.
| Device ID | K926450 |
| 510k Number | K926450 |
| Device Name: | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Ponzoa Parker |
| Correspondent | Ponzoa Parker BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-24 |
| Decision Date | 1993-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103000221 | K926450 | 000 |
| 00690103000207 | K926450 | 000 |