# K020213: Netlink/Netscan

- Pathway: 510(k) (Traditional)
- Applicant: Rozinn Electronics, Inc.
- Decided: Apr 5, 2002 after 73 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930806 (1994). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982090: Paceart Home Trak Plus Easi Event Recorder System, Paceart, Inc. (1999) Summary page 1.

## Most influential descendants
- K042002: Synescope, Easyscope, Synecom, Holterreader (2004), 3 descendants of its own
- K193177: CER-S (2020), 2 descendants of its own
- K213861: CER-S (2022), 1 descendant of its own
- K243312: CER-S (2025), 0 descendants of its own

## Indications for use
The Netlink/Netscan is a transmission software which will transmit ECG, ambulatory blood pressure, EKG, spirometry, and any other data files from a remote site to a central station for analysis using a modem, cable modera, ISDN line, T1 lines, DSL, Internet or Intranet and send the analyzed data back to the remote site from the central site using the same transmission media.

Source page: https://510kreport.com/device/K020213
Methodology: https://510kreport.com/methodology