The following data is part of a premarket notification filed by Bruel & Kjaer Industri A/s with the FDA for Rhino-larynx Stroboscope Type 4914.
Device ID | K842090 |
510k Number | K842090 |
Device Name: | RHINO-LARYNX STROBOSCOPE TYPE 4914 |
Classification | Laryngostroboscope |
Applicant | BRUEL & KJAER INDUSTRI A/S 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EQL |
CFR Regulation Number | 874.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-24 |
Decision Date | 1984-07-18 |