The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Mactrode-ii.
Device ID | K872784 |
510k Number | K872784 |
Device Name: | MACTRODE-II |
Classification | Electrode, Electrocardiograph |
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 | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-14 |
Decision Date | 1987-10-09 |