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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received01/28/1980
Decision Date07/28/1980
Withdrawal Date 09/10/2007
Product Code
JEZ
Docket Number 80M-0317
Notice Date 09/12/1980
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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