The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning 248 Ph/blood Gas Analyzer.
| Device ID | K935830 |
| 510k Number | K935830 |
| Device Name: | CIBA CORNING 248 PH/BLOOD GAS ANALYZER |
| 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 |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-07 |
| Decision Date | 1994-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414194455 | K935830 | 000 |
| 00630414106564 | K935830 | 000 |
| 00630414112077 | K935830 | 000 |
| 00630414112107 | K935830 | 000 |
| 00630414112121 | K935830 | 000 |
| 00630414112183 | K935830 | 000 |
| 00630414112206 | K935830 | 000 |
| 00630414114934 | K935830 | 000 |
| 00630414115269 | K935830 | 000 |
| 00630414117539 | K935830 | 000 |
| 00630414106540 | K935830 | 000 |