SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER— 510(k) K031738
Substantially EquivalentSmiths Medical MD, Inc.
FDA 510(k) clearance K031738 for SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER, Substantially Equivalent on 2004-05-27. Applicant: Smiths Medical MD, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical MD, 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
- St. Paul, MN, US
Recent devices under product code LZG
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- K082783 — CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
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.