The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning 288 Ph/blood Gas System.
Device ID | K872888 |
510k Number | K872888 |
Device Name: | CIBA CORNING 288 PH/BLOOD GAS SYSTEM |
Classification | Ph Meter |
Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
Contact | William J Pignato |
Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
Product Code | JQY |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-23 |
Decision Date | 1987-08-25 |