The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Ao Stylet Laryngoscope Model Sls.
Device ID | K801364 |
510k Number | K801364 |
Device Name: | AO STYLET LARYNGOSCOPE MODEL SLS |
Classification | Laryngoscope, Non-rigid |
Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAL |
CFR Regulation Number | 868.5530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-10 |
Decision Date | 1980-06-17 |