510(k) K842090

RHINO-LARYNX STROBOSCOPE TYPE 4914 by Bruel & Kjaer Industri A/S — Product Code EQL

K842090 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer Industri A/S for the device "RHINO-LARYNX STROBOSCOPE TYPE 4914". The FDA issued a decision of Substantially Equivalent on July 18, 1984. The device falls under product code EQL (Laryngostroboscope), a Class I device regulated under 21 CFR 874.4750. Bruel & Kjaer Industri A/S has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1984
Date Received
May 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngostroboscope
Device Class
Class I
Regulation Number
874.4750
Review Panel
EN
Submission Type