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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.
 
Trade NameMODEL 9310 LUNG WATER COMPUTER
Classification Namemonitor, lung water measurement
Generic Namelung water monitor
Regulation Number868.2450
ApplicantEDWARDS LIFESCIENCES LLC.
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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