The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Bi-otoscope.
Device ID | K955043 |
510k Number | K955043 |
Device Name: | WELCH ALLYN BI-OTOSCOPE |
Classification | Otoscope |
Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Contact | Colin Wolff |
Correspondent | Colin Wolff WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Product Code | ERA |
CFR Regulation Number | 874.4770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-03 |
Decision Date | 1995-11-14 |