The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Defib Electrodes.
Device ID | K952101 |
510k Number | K952101 |
Device Name: | MARQUETTE DEFIB ELECTRODES |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
Contact | Michael T Laughran |
Correspondent | Michael T Laughran MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-04 |
Decision Date | 1995-09-07 |