NASO-LARYNGO-PHARYNGOSCOPE— 510(k) K991560

Substantially Equivalent

Fiber Imaging Technologies, Inc.

FDA 510(k) clearance K991560 for NASO-LARYNGO-PHARYNGOSCOPE, Substantially Equivalent on 1999-07-13. Applicant: Fiber Imaging Technologies, Inc..

Clearance details

Applicant
Fiber Imaging Technologies, Inc.
Product code
Code EOB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newton, MA, US
Download summary PDFView on FDA.gov ↗

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.