SCANNER, CT 0450

System, X-ray, Tomography, Computed

PFIZER MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Pfizer Medical Systems, Inc. with the FDA for Scanner, Ct 0450.

Pre-market Notification Details

Device IDK781752
510k NumberK781752
Device Name:SCANNER, CT 0450
ClassificationSystem, X-ray, Tomography, Computed
Applicant PFIZER MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-18
Decision Date1978-11-03

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