The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Series 360 Defibrillator.
Device ID | K921487 |
510k Number | K921487 |
Device Name: | MARQUETTE SERIES 360 DEFIBRILLATOR |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Gerry Buss |
Correspondent | Gerry Buss MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-30 |
Decision Date | 1992-12-29 |