MEDLEY SP02 MODULE, MODEL 8220— 510(k) K010966
Substantially EquivalentAlaris Medical Systems, Inc.
FDA 510(k) clearance K010966 for MEDLEY SP02 MODULE, MODEL 8220, Substantially Equivalent on 2001-06-08. Applicant: Alaris Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Alaris Medical Systems, Inc.
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DQA
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- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Alaris Medical Systems, Inc.
view all- K043299 — MEDLEY PCA MODULE, MODEL 8120
- 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
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.