# K993620: Impresario

- Pathway: 510(k) (Special)
- Applicant: Del Mar Medical Systems, LLC
- Decided: Nov 12, 1999 after 17 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Del Mar Avionics Model 263 Spectrascan®: named in the summary without a submission number

## Most influential descendants
- K110001: Spacelabs Pathfinder SL Holter Analyzer (2011), 6 descendants of its own
- K110569: Audicor Cpam (Cardiopulmonary Ambulatory Monitor) (2011), 4 descendants of its own
- K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) (2012), 3 descendants of its own
- K131883: Audicor Cpam with SDB (Accelerometer Based) (2014), 1 descendant of its own
- K201921: Spacelabs Lifescreen PRO Analyzer (2021), 0 descendants of its own

## Indications for use
The Impresario™ software is intended for the analysis, summary and reporting of prerecorded ambulatory ECG data. At the requirement of a clinician, ambulatory ECG data is recorded in analog or digital form for up to 48 hours in multiple channels. The resultant recordings are segregated into a series of reports presenting significant clinical events as defined by the system, and affirmed by the review and confirmation of a clinician. The system is employed as a screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment.

Source page: https://510kreport.com/device/K993620
Methodology: https://510kreport.com/methodology