AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010— 510(k) K003999

Name: FDA 510(k) clearance K003999
Creator: U.S. Food and Drug Administration
Published: 2001-06-28

Substantially Equivalent

American Telecare, Inc.

FDA 510(k) clearance K003999 for AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010, Substantially Equivalent on 2001-06-28. Applicant: American Telecare, Inc.. Device class: 2.

Clearance details

Applicant: American Telecare, Inc.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2000-12-26
Decision date: 2001-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Telecare, Inc.

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K030222 — NX SYSTEM2003-08-19
K993550 — AVIVA SYSTEM, MODEL SL10102000-01-13
K981533 — AVIVA SYSTEMS MODEL NUMBERS 1010, 20201998-07-15
K973873 — DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 11997-12-29
K963678 — CARETONE II1997-02-24

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.