DIAG. CONSOLE, INDEPENDENT

System, X-ray, Tomography, Computed

PFIZER, INC.

The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Diag. Console, Independent.

Pre-market Notification Details

Device IDK772291
510k NumberK772291
Device Name:DIAG. CONSOLE, INDEPENDENT
ClassificationSystem, X-ray, Tomography, Computed
Applicant PFIZER, 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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