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 |