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FDA 510(k) Application Details - K203658
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
510(K) Number
K203658
Device Name
System, X-Ray, Mobile
Applicant
OXOS Medical, Inc.
1230 Peachtree Street NE
Suite 300
Atlanta, GA 30309 US
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Contact
Evan Ruff
Other 510(k) Applications for this Contact
Regulation Number
892.1720
More FDA Info for this Regulation Number
Classification Product Code
IZL
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More FDA Info for this Product Code
Date Received
12/15/2020
Decision Date
01/12/2021
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
Y
Expedited Review
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