MEDLEY PCA MODULE, MODEL 8120— 510(k) K043299
Substantially EquivalentAlaris Medical Systems, Inc.
FDA 510(k) clearance K043299 for MEDLEY PCA MODULE, MODEL 8120, Substantially Equivalent on 2004-12-10. Applicant: Alaris Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Alaris Medical Systems, Inc.
- Product code
- Code MEA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Alaris Medical Systems, Inc.
view all- K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
- K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
- K032233 — MEDLEY PCA MODULE, MODEL 8120
- K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
- K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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 →
Recalls naming K043299
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043299.
Data sourced from openFDA. This site is unofficial and independent of the FDA.