The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for K 750 Computer/data Processor.
Device ID | K801091 |
510k Number | K801091 |
Device Name: | K 750 COMPUTER/DATA PROCESSOR |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-08 |
Decision Date | 1980-06-09 |