The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for 860 Measurment System.
| Device ID | K934907 |
| 510k Number | K934907 |
| Device Name: | 860 MEASURMENT 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 |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-15 |
| Decision Date | 1994-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414515144 | K934907 | 000 |
| 00630414112169 | K934907 | 000 |
| 00630414112275 | K934907 | 000 |
| 00630414112343 | K934907 | 000 |
| 00630414112350 | K934907 | 000 |
| 00630414121154 | K934907 | 000 |
| 00630414132013 | K934907 | 000 |
| 00630414132075 | K934907 | 000 |
| 00630414468143 | K934907 | 000 |
| 00630414051499 | K934907 | 000 |