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EQNClass II

Laryngoscope, Nasopharyngoscope

21 CFR 874.4760 / Ear, Nose, Throat

EQN is the FDA product code for Laryngoscope, Nasopharyngoscope, a class II device type, regulated under 21 CFR 874.4760. FDA's definition for this code reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)". As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
EQN
Device name
Laryngoscope, Nasopharyngoscope
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Regulation
21 CFR 874.4760
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
22
Ingested recalls
2

Clearances, product code EQN

By decision year
22 clearances under product code EQN with a decision year between 1977 and 2026, 1982 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code EQN by decision year
YearClearances
19771
19782
19791
19812
198210
19832
19841
20141
20151
20261

Applicants with the most clearances

Product code EQN

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order