ESOPHAGEAL MOTILITY APPARATUS

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 Apparatus.

Pre-market Notification Details

Device IDK812103
510k NumberK812103
Device Name:ESOPHAGEAL MOTILITY APPARATUS
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant HONEYWELL, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-24
Decision Date1981-08-13

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