510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Cardiopulmonary Instrumentation

Mchenry, IL, US

Cardiopulmonary Instrumentation appears in FDA device records in Mchenry, IL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Cardiopulmonary Instrumentation in 1976.

Clearances by year, as a table
510(k) clearance decisions for Cardiopulmonary Instrumentation, by decision year
YearClearances
19761
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K760600CARDIAC OUTPUT COMPUTERDXGSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1013-2012CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This stainless steel stretcher is used for transporting patients.Cardiopulmonary Instrumentation, Inc. dba CI Healthcare, Miami, FL, is recalling their Stainless Steel Patient Transport Stretcher, model # CI-8092, Lot 002, because of a malfunction that occurs when weight is applied to the backrest. This malfunction causes the backrest support bar, when secured in the first hook, to fall to a flat position.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain