# K993550: Aviva System, Model SL1010

- Pathway: 510(k) (Traditional)
- Applicant: American Telecare, Inc.
- Decided: Jan 13, 2000 after 85 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) American TeleCare’s Personal Telemedicine Module: named in the summary without a submission number
- (no number) American TeleCare’s Digital Personal Telemedicine Module: named in the summary without a submission number
- (no number) American TeleCare’s Personal Telemedicine System: named in the summary without a submission number

## Indications for use
The Aviva SLX System is intended for use as a monitoring device, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure, pulse and glucose readings, as well as to listen to the patient's heart and lung sounds.

Source page: https://510kreport.com/device/K993550
Methodology: https://510kreport.com/methodology