The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Centralscope 12.
Device ID | K901072 |
510k Number | K901072 |
Device Name: | CENTRALSCOPE 12 |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Sandra L Schick |
Correspondent | Sandra L Schick MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-07 |
Decision Date | 1990-08-23 |