# K962930: Spacelabs Medical Ecg Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Apr 25, 1997 after 270 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 K844940 (1985). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844940: Spacelabs Model 90201 Holter Recorder, Spacelabs, Inc. (1985) Summary page 1.
- K942781: Digital Holter Recorder, Agilent Technologies (1995) Summary page 1.
- K895208: Zymed Model 1610, Agilent Technologies (1989) Summary page 1.

## Most influential descendants
- K063490: Spacelabs Medical Full Disclosure System, Model 91810 (2007), 1 descendant of its own
- K110779: Spacelabs Smart Disclosure System (2011), 0 descendants of its own

## Indications for use
The Spacelabs Medical Cardiology Workstation is intended for use with the SpacelLabs Medical ECC Recorder to provide for the analysis of ambulatory ECG data. After the recording is made on the ECG Recorder, the Cardiology Workstation analyzes the ECG waveform data for the duration of the recording and produces a series of reports summarizing the overall activity on the recording and highlighting significant clinical events. The system provides for review of the automated analysis and for a qualified user to make editing changes to the automated results. The Cardiology Workstation can also receive input from an analog-based cassette tape ambulatory recorder and an infrared serial link, as well as from the SpacelLabs PCMS monitoring network to provide for the collection, review, editing, printing and archiving of waveform data records.

Source page: https://510kreport.com/device/K962930
Methodology: https://510kreport.com/methodology