POLYPHOS 500

Generator, High-voltage, X-ray, Diagnostic

SIEMENS CORP.

The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Polyphos 500.

Pre-market Notification Details

Device IDK812616
510k NumberK812616
Device Name:POLYPHOS 500
ClassificationGenerator, High-voltage, X-ray, Diagnostic
Applicant SIEMENS CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeIZO  
CFR Regulation Number892.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-15
Decision Date1981-10-13

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