The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Mac-lab Cardiac Catheterization Laboratory System.
| Device ID | K895801 |
| 510k Number | K895801 |
| Device Name: | MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MARQUETTE ELECTRONICS, INC. 1002 JUPITER PARK LANE, UNIT 1 Jupiter, FL 33458 |
| Contact | Thomas Divers,phd |
| Correspondent | Thomas Divers,phd MARQUETTE ELECTRONICS, INC. 1002 JUPITER PARK LANE, UNIT 1 Jupiter, FL 33458 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-28 |
| Decision Date | 1990-04-04 |