SCANNER, CT, 0400

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, 0400.

Pre-market Notification Details

Device IDK772289
510k NumberK772289
Device Name:SCANNER, CT, 0400
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 Received1977-12-12
Decision Date1977-12-21

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