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FDA 510(k) Application Details - K210365
Device Classification Name
Analyzer,Medical Image
More FDA Info for this Device
510(K) Number
K210365
Device Name
Analyzer,Medical Image
Applicant
Pearl Inc.
2515 Benedict Canyon Drive
Beverly Hills, CA 90210 US
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Contact
Bill Birdsall
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MYN
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More FDA Info for this Product Code
Date Received
02/08/2021
Decision Date
03/04/2022
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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