MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385— 510(k) K010377
Substantially EquivalentMinimed, Inc.
FDA 510(k) clearance K010377 for MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385, Substantially Equivalent on 2001-04-05. Applicant: Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Minimed, Inc.
- Product code
- Code KZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.6920
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
Recent devices under product code KZH
view allMore clearances from Minimed, Inc.
view all- K031541 — PARADIGMPAL, MODEL MMT-7330
- K031390 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
- K030531 — MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
- K021974 — MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
- K001827 — PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
Adverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
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.