The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Audioscope #23000 W/71123 Charging Stand.
Device ID | K831709 |
510k Number | K831709 |
Device Name: | AUDIOSCOPE #23000 W/71123 CHARGING STAND |
Classification | Otoscope |
Applicant | WELCH ALLYN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ERA |
CFR Regulation Number | 874.4770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-26 |
Decision Date | 1983-06-30 |