The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Bodytrode.
Device ID | K961288 |
510k Number | K961288 |
Device Name: | BODYTRODE |
Classification | Electrode, Electrocardiograph |
Applicant | MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
Contact | Michael Laughran |
Correspondent | Michael Laughran MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-04 |
Decision Date | 1996-08-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BODYTRODE 75195395 not registered Dead/Abandoned |
Marquette Medical Systems, Inc. 1996-11-08 |
BODYTRODE 74364447 not registered Dead/Abandoned |
Marquette Electronics, Inc. 1993-03-03 |