The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for 7610 Colorview Slave Scope.
Device ID | K890481 |
510k Number | K890481 |
Device Name: | 7610 COLORVIEW SLAVE SCOPE |
Classification | Electrocardiograph |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Thomas Massopust |
Correspondent | Thomas Massopust MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-31 |
Decision Date | 1989-03-31 |