ILLIMINATOR, MODEL 265 NASAL

Otoscope

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Illiminator, Model 265 Nasal.

Pre-market Notification Details

Device IDK782142
510k NumberK782142
Device Name:ILLIMINATOR, MODEL 265 NASAL
ClassificationOtoscope
Applicant WELCH ALLYN, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeERA  
CFR Regulation Number874.4770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-27
Decision Date1979-01-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.