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FDA 510(k) Application Details - K000396
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K000396
Device Name
Ventilatory Effort Recorder
Applicant
ERICH JAEGER, INC.
22705 SAVI RANCH PKWY.
YORBA LINDA, CA 92887-4645 US
Other 510(k) Applications for this Company
Contact
LARRY MURDOCK
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
02/07/2000
Decision Date
12/27/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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