DeviceClearance

ESOPHAGEAL MOTILITY APPARATUS— 510(k) K812103

Substantially Equivalent

Honeywell, Inc.

FDA 510(k) clearance K812103 for ESOPHAGEAL MOTILITY APPARATUS, Substantially Equivalent on 1981-08-13. Applicant: Honeywell, Inc.. Device class: 2.

Clearance details

Applicant
Honeywell, Inc.
Product code
Code FFX
Device class
Class 2
Regulation
21 CFR 876.1725
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FFX

product code FFX
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.