The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Series 1500 Defibrillator, Modification.
Device ID | K926172 |
510k Number | K926172 |
Device Name: | SERIES 1500 DEFIBRILLATOR, MODIFICATION |
Classification | Automated External Defibrillators (non-wearable) |
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 | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1993-02-25 |