MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER— 510(k) K030531
Substantially EquivalentMinimed, Inc.
FDA 510(k) clearance K030531 for MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER, Substantially Equivalent on 2003-06-17. Applicant: Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Minimed, Inc.
- Product code
- Code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
Recent devices under product code LZG
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view all- K031541 — PARADIGMPAL, MODEL MMT-7330
- K031390 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
- K021974 — MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
- K010377 — MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
- K001827 — PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
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, through . 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.