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FDA 510(k) Application Details - K202635
Device Classification Name
Monitor, Pressure, Intracompartmental
More FDA Info for this Device
510(K) Number
K202635
Device Name
Monitor, Pressure, Intracompartmental
Applicant
MY01, Inc.
400 De Maisonneuve Boulevard West, Suite 700
Montreal H3A 1L4 CA
Other 510(k) Applications for this Company
Contact
Charles Allan
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/11/2020
Decision Date
12/10/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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