FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

RHINO-LARYNX STROBOSCOPE TYPE 4914

K Number: K842090 · Decision Jul 18, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
7
Applicant Total
4
Review Days
55

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Basic Information

Device Name
RHINO-LARYNX STROBOSCOPE TYPE 4914
K Number
K842090
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
874.4750
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Applicant
Bruel & Kjaer Industri A/S
Date Received
May 24, 1984
Decision Date
July 18, 1984
Product Code
EQL
Advisory Committee
Ear, Nose, Throat
Review Advisory Committee
EN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EQL Laryngostroboscope

Similar 510(k) Clearances

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Other Clearances by Bruel & Kjaer Industri A/S

K Number Device Name
K914945 DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED
K875357 BIOPSY FIXATION UNIT-TYPE UA 0997
K852502 AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849