The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Fiber Optic Laryngoscopes W/battery.
Device ID | K830047 |
510k Number | K830047 |
Device Name: | FIBER OPTIC LARYNGOSCOPES W/BATTERY |
Classification | Laryngoscope, Rigid |
Applicant | WELCH ALLYN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-10 |
Decision Date | 1983-01-18 |