The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Union Carbide Corp. Computer Interface.
Device ID | K790336 |
510k Number | K790336 |
Device Name: | UNION CARBIDE CORP. COMPUTER INTERFACE |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | UNION CARBIDE CORP. 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 | 1979-02-21 |
Decision Date | 1979-04-04 |