LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP— 510(k) K080743
Substantially EquivalentSmiths Medical MD, Inc.
FDA 510(k) clearance K080743 for LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP, Substantially Equivalent on 2008-04-25. Applicant: Smiths Medical MD, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical MD, Inc.
- Product code
- Code FRN
- 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
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More clearances from Smiths Medical MD, Inc.
view all- K112407 — SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
- K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
- K101180 — GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
- K091181 — LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
- K082783 — CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.