# K992948: Mac-Lab System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Nov 29, 1999 after 90 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895801 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895801: Mac-Lab Cardiac Catheterization Laboratory System, Marquette Electronics, Inc. (1990) Summary page 1.
- K935394: Mac-Lab Electrophysiology Module Option, Marquette Electronics, Inc. (1994) Summary page 1.

## Indications for use
The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Marquette TRAM modules (k921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (Sp0,), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization Intended for use in catheterization and related cardiovascular specialty labs

Source page: https://510kreport.com/device/K992948
Methodology: https://510kreport.com/methodology