Atlas FDA

MEDLEY PCA MODULE, MODEL 8120

FDA 510(k) clearance K032233 · decided 2003-09-09

Clearance details

K-number
K032233
Device name
MEDLEY PCA MODULE, MODEL 8120
Applicant
Alaris Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2003-07-21
Decision date
2003-09-09
Days to decision
50 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
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Recalls involving this device

RecordFirmDate
Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Al recall (Z-1794-2009)Cardinal Health 303 dba Cardinal Health2009-08-03
Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 u recall (Z-1237-2009)Cardinal Health 303 dba Cardinal Health2009-05-01