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FDA 510(k) Application Details - K003939
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K003939
Device Name
Generator, Oxygen, Portable
Applicant
INVACARE CORP.
ONE INVACARE WAY
ELYRIA, OH 44036-2125 US
Other 510(k) Applications for this Company
Contact
EDWARD A KROLL
Other 510(k) Applications for this Contact
Regulation Number
868.5440
More FDA Info for this Regulation Number
Classification Product Code
CAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2000
Decision Date
03/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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