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FDA 510(k) Application Details - K220028
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K220028
Device Name
Ventilatory Effort Recorder
Applicant
Ectosense nv
Bosbessenlaan 19A
Rotselaar 3110 BE
Other 510(k) Applications for this Company
Contact
Bart Van Pee
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
01/05/2022
Decision Date
02/24/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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