510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K828564Substantially Equivalent

Computer Data Monitoring System

Siemens Medical Solutions USA, Inc., Issaquah WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828564 is the FDA 510(k) clearance record for COMPUTER DATA MONITORING SYSTEM, cleared for Siemens Medical Solutions USA, Inc. on . FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K828564.

Clearance record

Decision date
Received
(87 days to decision)
Review panel
Unknown
Applicant
Siemens Medical Solutions USA, Inc. 22010 SE 51st St., Issaquah WA
Third party review
No