The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette 1200 Defibrillator.
Device ID | K882067 |
510k Number | K882067 |
Device Name: | MARQUETTE 1200 DEFIBRILLATOR |
Classification | Automated External Defibrillators (non-wearable) |
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 | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-17 |
Decision Date | 1988-11-17 |