ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330

System, Gastrointestinal Motility (electrical)

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Esophageal Motility System - Model 3330.

Pre-market Notification Details

Device IDK780812
510k NumberK780812
Device Name:ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-05-17
Decision Date1978-06-13

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