The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Clinifacts 200 Data Management System.
Device ID | K861778 |
510k Number | K861778 |
Device Name: | CLINIFACTS 200 DATA MANAGEMENT SYSTEM |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
Contact | John H Engelmann |
Correspondent | John H Engelmann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
Product Code | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-08 |
Decision Date | 1986-07-02 |