Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MODEL 9310 LUNG WATER COMPUTER |
Generic Name | MONITOR, LUNG WATER MEASUREMENT |
Regulation Number | 868.2450 |
Applicant | EDWARDS LIFESCIENCES LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P800003 |
Supplement Number | S001 |
Date Received | 03/17/1981 |
Decision Date | 06/12/1981 |
Withdrawal Date
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09/10/2007 |
Product Code |
JEZ |
Advisory Committee |
Anesthesiology |
Expedited Review Granted? | No |
Combination Product | No |
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