The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Du Pont Ise Sensor Cartridge/revised Tco2 Electrod.
| Device ID | K932044 |
| 510k Number | K932044 |
| Device Name: | DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | DUPONT MEDICAL PRODUCTS BMP 22/1168 Wilmington, DE 19880 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DUPONT MEDICAL PRODUCTS BMP 22/1168 Wilmington, DE 19880 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1993-07-27 |