510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OQUClass II

Airway Monitoring System

21 CFR 868.5730 / Anesthesiology
FDA source (opens on fda.gov)

OQU is the FDA product code for Airway Monitoring System, a class II device type, regulated under 21 CFR 868.5730. FDA's definition for this code reads: "The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
OQU
Device name
Airway Monitoring System
FDA definition
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
6

Clearances, product code OQU

By decision year
3 clearances under product code OQU with a decision year between 2010 and 2020, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OQU by decision year
YearClearances
20101
20161
20201

Applicants with the most clearances

Product code OQU
Applicants holding the most 510(k) clearances under product code OQU
ApplicantClearances
Sonarmed, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code