Atlas FDA

MEDLEY PCA MODULE, MODEL 8120

FDA 510(k) clearance K043299 · decided 2004-12-10

Clearance details

K-number
K043299
Device name
MEDLEY PCA MODULE, MODEL 8120
Applicant
Alaris Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2004-11-30
Decision date
2004-12-10
Days to decision
10 days
Clearance type
Traditional
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256)Hospira, Inc.2004-12-06
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042800)Hospira, Inc.2004-10-18
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054)Harvard Clinical Technology2003-12-16
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Recalls involving this device

RecordFirmDate
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Mo recall (Z-2882-2020)CareFusion 303, Inc.2020-09-04
Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built recall (Z-1711-2008)Cardinal Health 303 Inc DBA Alaris Products2008-06-10
U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System recall (Z-1712-2008)Cardinal Health 303 Inc DBA Alaris Products2008-06-10