NASOPHARYNGOSCOPE— 510(k) K934422

Substantially Equivalent

Marks & Murase

FDA 510(k) clearance K934422 for NASOPHARYNGOSCOPE, Substantially Equivalent on 1994-01-27. Applicant: Marks & Murase. Device class: 2.

Clearance details

Applicant
Marks & Murase
Product code
Code EOB
Device class
Class 2
Regulation
21 CFR 874.4760
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

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.