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FDA 510(k) Application Details - K021138
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K021138
Device Name
Ventilatory Effort Recorder
Applicant
ERICH JAEGER GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA, CA 92887-4645 US
Other 510(k) Applications for this Company
Contact
BRIAN LONG
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
MNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2002
Decision Date
02/12/2003
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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