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FDA 510(k) Application Details - K211803
Device Classification Name
More FDA Info for this Device
510(K) Number
K211803
Device Name
HealthPPT
Applicant
Zebra Medical Vision Ltd.
Shefayim Commercial Center, PO Box 25
Sefayim 6099000 IL
Other 510(k) Applications for this Company
Contact
Shlomit Cymbalista
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QFM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/11/2021
Decision Date
12/15/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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