The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il 482 Co-oximeter.
Device ID | K862253 |
510k Number | K862253 |
Device Name: | IL 482 CO-OXIMETER |
Classification | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide |
Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
Contact | George A Lyna |
Correspondent | George A Lyna INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
Product Code | JKS |
CFR Regulation Number | 862.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-13 |
Decision Date | 1986-07-29 |