The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Synthesis.
Device ID | K963800 |
510k Number | K963800 |
Device Name: | IL SYNTHESIS |
Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
Contact | Betty J Lane |
Correspondent | Betty J Lane INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
Product Code | CHL |
Subsequent Product Code | CEM |
Subsequent Product Code | CGA |
Subsequent Product Code | CGZ |
Subsequent Product Code | GFK |
Subsequent Product Code | GLY |
Subsequent Product Code | JFP |
Subsequent Product Code | JGS |
CFR Regulation Number | 862.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-23 |
Decision Date | 1996-11-13 |
Summary: | summary |