510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K837343Substantially Equivalent

Pz-600 Computerized Axial Tomography Scanner

Phoenix Medical Electronics, Chantilly VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837343 is the FDA 510(k) clearance record for PZ-600 COMPUTERIZED AXIAL TOMOGRAPHY SCANNER, cleared for Phoenix Medical Electronics on . FDA records list one 510(k) clearance for Phoenix Medical Electronics. As of , FDA records show no recalls naming K837343.

Clearance record

Decision date
Received
(92 days to decision)
Review panel
Unknown
Applicant
Phoenix Medical Electronics 14310 Sullyfield Cir., #200, Chantilly VA
Third party review
No