MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311— 510(k) K993012

Name: FDA 510(k) clearance K993012
Creator: U.S. Food and Drug Administration
Published: 1999-11-15

Substantially Equivalent - Subject to Tracking Reg.

Medtronic Minimed

FDA 510(k) clearance K993012 for MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311, Substantially Equivalent - Subject to Tracking Reg. on 1999-11-15. Applicant: Medtronic Minimed. Device class: 2.

Clearance details

Applicant: Medtronic Minimed
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1999-09-08
Decision date: 1999-11-15
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.