The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Mac-lab Electrophysiology Module Option.
| Device ID | K935394 |
| 510k Number | K935394 |
| Device Name: | MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION |
| Classification | Electrocardiograph |
| Applicant | MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Contact | Richard A Crane |
| Correspondent | Richard A Crane MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-10-20 |