The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning 400 System.
| Device ID | K961657 |
| 510k Number | K961657 |
| Device Name: | CIBA CORNING 400 SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKF |
| Subsequent Product Code | JFP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-30 |
| Decision Date | 1996-06-25 |
| Summary: | summary |