The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Illiminator, Model 265 Nasal.
Device ID | K782142 |
510k Number | K782142 |
Device Name: | ILLIMINATOR, MODEL 265 NASAL |
Classification | Otoscope |
Applicant | WELCH ALLYN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ERA |
CFR Regulation Number | 874.4770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-27 |
Decision Date | 1979-01-26 |