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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMODEL 9310 LUNG WATER COMPUTER
Classification Namemonitor, lung water measurement
Generic Namemonitor, lung water measurement
Regulation Number868.2450
Applicant
EDWARDS LIFESCIENCES LLC.
one edwards way
irvine, CA 92614
PMA NumberP800003
Supplement NumberS001
Date Received03/17/1981
Decision Date06/12/1981
Product Code
JEZ
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
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